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Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01636778
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : February 23, 2015
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Intervention Drug: SB-497115-GR
Enrollment 45
Recruitment Details Participants with chronic hepatitis C (CHC) or compensated liver cirrhosis, who cannot start polyethylene glycol (Peg)-interferon (IFN)/ribavirin (RBV) therapy due to thrombocytopenia (platelet count <80 giga (10^9) cells per liter (Gi/L).
Pre-assignment Details The total study duration was a maximum of 88 weeks, which consisted of a Screening Period of less than or equal to 45 days, the Pre-Antiviral Treatment Period (Part 1) from 1 up to 9 weeks and the Antiviral Treatment Period (Part 2) of 48 weeks and Follow-up Period of 24 weeks.
Arm/Group Title Eltrombopag Dose Escalation: Part 1 Eltrombopag + Antiviral Therapy: Part 2 Eltrombopag + Antiviral Therapy: Follow-up Period After Part
Hide Arm/Group Description Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period. Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count. Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Period Title: Pre-Antiviral Treatment Period (Part 1)
Started 45 0 0
Completed 41 0 0
Not Completed 4 0 0
Reason Not Completed
Protocol Violation             3             0             0
Protocol-Defined Stopping Criteria             1             0             0
Period Title: Antiviral Treatment Period (Part 2)
Started 0 41 0
Completed 0 31 0
Not Completed 0 10 0
Reason Not Completed
Adverse Event             0             7             0
Protocol Violation             0             1             0
Physician Decision             0             2             0
Period Title: Follow-up Period After Part 2
Started 0 0 41
Completed 0 0 37
Not Completed 0 0 4
Reason Not Completed
Other             0             0             1
Not entered FU period after withdrawal             0             0             1
Withdrawal by Subject             0             0             2
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
57.8  (9.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
30
  66.7%
Male
15
  33.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 45 participants
45
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
Chronic hepatitis C 23
Liver cirrosis 22
HCV genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
1a 0
1b 33
2a 6
2b 5
Others 1
Child-Pugh Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
A (Score 5 - 6) 44
B (Score 7 - 9) 1
C (Score > 9) 0
[1]
Measure Description: The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe) is calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5-6 = Class A (mild); 7-9 = Class B (moderate); >9 = Class C (severe).
Number of Participants with or without previous IFN use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
Naïve 24
Experienced 21
Baseline alanine transaminase (ALT)  
Mean (Standard Deviation)
Unit of measure:  IU/L
Number Analyzed 45 participants
78.2  (47.82)
Baseline Hepatitis C Virus (HCV) RNA  
Mean (Standard Deviation)
Unit of measure:  Log IU/mL
Number Analyzed 45 participants
6.41  (0.706)
Baseline platelet counts  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
<50 Gi Platelets/L 8
>=50 Gi Platelets/L 37
1.Primary Outcome
Title Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1
Hide Description Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.
Time Frame From Baseline up to Week 9 in Part 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
43
2.Primary Outcome
Title Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2
Hide Description

Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2.

Platelet counts were measured by blood draw.

Time Frame From Antiviral Baseline to up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eltrombopag + Antiviral Therapy: Part 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 88
Confidence Interval (2-Sided) 95%
74 to 96
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Median Platelet Count at the Indicated Time Points in Part 1
Hide Description Platelet counts were measured by blood draw
Time Frame Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Median (Full Range)
Unit of Measure: 10^9 Cells Per Liter (Gi/L)
Baseline, n=45
63.0
(34 to 78)
Week 1, n=43
74.0
(36 to 108)
Week 2, n=36
100.0
(43 to 248)
Week 3, n=17
97.0
(48 to 153)
Week 4, n=9
104.0
(48 to 137)
Week 5, n=4
87.0
(49 to 132)
Week 6, n=3
83.0
(53 to 93)
Week 7, n=3
97.0
(56 to 103)
Week 8, n=2
79.0
(63 to 95)
Week 9, n=1
100.0
(100 to 100)
Withdrawal, n=4
96
(48 to 115)
4.Secondary Outcome
Title Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Hide Description Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw.
Time Frame From Baseline up to Week 9 in Part 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 Population: all participants enrolled in Part 1.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Participants
Within 2 Weeks 11
Within 4 Weeks 25
Within 6 Weeks 5
Within 8 Weeks 1
Within 9 Weeks 0
Greater than 9 Weeks 1
5.Secondary Outcome
Title Median Platelet Count at the Indicated Time Points in Part 2
Hide Description Platelet counts were measured by blood draw
Time Frame Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: Gi/L
Antiviral Baseline, n=41
114.0
(100 to 248)
Week 1, n=40
106.5
(50 to 431)
Week 2, n=40
118.0
(58 to 309)
Week 4, n=37
89.0
(43 to 126)
Week 6, n=36
86.0
(38 to 130)
Week 8, n=36
79.5
(53 to 130)
Week 12, n=36
80.5
(55 to 161)
Week 16, n=36
79.5
(49 to 128)
Week 20, n=36
75.5
(54 to 119)
Week 24, n=36
76.5
(29 to 128)
Week 28, n=34
75.0
(49 to 128)
Week 32, n=34
73.0
(30 to 161)
Week 36, n=34
76.0
(43 to 148)
Week 40, n=33
80.0
(48 to 135)
Week 44, n=31
79.0
(37 to 172)
Week 48, n=31
82.0
(49 to 170)
Withdrawal, n=10
102.0
(54 to 207)
6.Secondary Outcome
Title Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2
Hide Description Platelet counts were measured by blood draw at specified timepoints.
Time Frame Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 34
Median (Full Range)
Unit of Measure: Gi/L
FU Baseline, n=34
86.5
(36 to 184)
FU Week 4, n=34
82.5
(43 to 645)
FU Week 12, n=34
70.0
(37 to 154)
FU Week 24, n=31
63.0
(41 to 145)
7.Secondary Outcome
Title Minimum Platelet Count on Antiviral Therapy
Hide Description

Participants were assessed for platelet counts during antiviral therapy in Part 2.

Platelet counts were measured by blood draw.

Time Frame From Antiviral Baseline to up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population: all participants enrolled in Part 2.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
<25 Gi/L 0
>=25 to <50 Gi/L 5
>=50 to <100 Gi/L 34
>=100 to <150 Gi/L 2
>=150 to <200 Gi/L 0
>=200 to <400 Gi/L 0
>= 400 Gi/L 0
8.Secondary Outcome
Title Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Hide Description Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.
Time Frame From Baseline up to Week 9 in Part 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 Population: all participants enrolled in Part 1.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Eltrombopag 0 mg 1
Eltrombopag 12.5 mg 25
Eltrombopag 25 mg 13
Eltrombopag 37.5 mg 0
Eltrombopag 50 mg 2
Did not initiate antiviral therapy 4
9.Secondary Outcome
Title Number of Antiviral Therapy Dose Reductions in Part 2
Hide Description Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
0 DR 8
1 DR 9
2 DR 10
3 DR 3
4 DR 2
5 DR 1
7 DR 3
8 DR 1
10 DR 2
10.Secondary Outcome
Title Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
Hide Description Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
0 DR 4
1 DR 6
2 DR 4
3 DR 1
>3 DR 1
11.Secondary Outcome
Title Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
Hide Description Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
0 DR 16
1 DR 2
2 DR 4
3 DR 0
>3 DR 3
12.Secondary Outcome
Title Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
Hide Description Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
0 DR 14
1 DR 12
2 DR 9
3 DR 3
>3 DR 3
13.Secondary Outcome
Title Time to First Dose Reduction of Antiviral Therapy in Part 2
Hide Description Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: weeks
Peg-IFN alfa-2a dose reduction, n=12 9.44  (12.556)
Peg-IFN alfa-2b dose reduction, n=9 6.22  (6.944)
RBV dose reduction, n=27 9.16  (6.611)
14.Secondary Outcome
Title Number of Participants Who Discontinued Antiviral Therapy in Part 2
Hide Description Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
8
15.Secondary Outcome
Title Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2
Hide Description Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
1
16.Secondary Outcome
Title Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2
Hide Description Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
7
17.Secondary Outcome
Title Number of Participants Achieving Adherence to Antiviral Therapy in Part 2
Hide Description Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
32
18.Secondary Outcome
Title Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2
Hide Description Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
14
19.Secondary Outcome
Title Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2
Hide Description Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
18
20.Secondary Outcome
Title Number of Participants With Sustained Virologic Response (SVR) in Part 2
Hide Description Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
9
21.Secondary Outcome
Title Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2
Hide Description RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
RVR 6
eRVR 5
22.Secondary Outcome
Title Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2
Hide Description EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
EVR 28
cEVR 18
23.Secondary Outcome
Title Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2
Hide Description ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
19
24.Secondary Outcome
Title Mean Serum HCV RNA at the Indicated Time Points In Part 2
Hide Description The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.
Time Frame Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: Log international unit per milliliter
Screening, n=41 6.41  (0.726)
Antiviral Baseline, n=41 6.37  (0.767)
Week 4, n=37 3.77  (1.741)
Week 12, n=36 2.52  (1.734)
Week 24, n=36 2.46  (1.876)
Week 36, n=34 2.69  (2.177)
Week 48, n=31 2.63  (2.275)
Withdrawal, n=10 3.87  (2.275)
25.Secondary Outcome
Title Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2
Hide Description The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2
Time Frame FU Baseline, FU Week 12 and FU Week 24 after Part 2
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Hide Analysis Population Description
FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
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Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: Log international unit per milliliter
FU Baseline, n=34 3.10  (2.422)
FU Week 12, n=34 5.04  (2.551)
FU Week 24, n=31 4.82  (2.436)
26.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time Frame From Baseline up to week 9 in Part 1
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Hide Analysis Population Description
Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Any AE 13
Any SAE 0
Fatal AE 0
Drug-related AE 4
AE leading to withdrawal 0
SAE leading to withdrawal 0
On-going AE at the endo of study/withdrawal 1
27.Secondary Outcome
Title Number of Participants With Any AE and Any SAE in Part 2
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time Frame From Antiviral Baseline up to Week 48 in Part 2
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Hide Analysis Population Description
Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
Any AE 41
Any SAE 3
Fatal AE 0
Drug-related AE 41
AE leading to withdrawal 9
SAE leading to withdrawal 3
On-going AE at the end of study/withdrawal 34
28.Secondary Outcome
Title Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time Frame From FU Baseline up to FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
Any AE 25
Any SAE 4
Fatal AE 0
Drug-related AE 6
AE leading to withdrawal 0
SAE leading to withdrawal 0
On-going AE at the end of study/withdrawal 16
29.Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
Hide Description Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time Frame Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24
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Hide Analysis Population Description
SP1
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
SBP, Week 1, n=38 0.9  (9.86)
SBP, Week 2, n=30 -1.7  (12.42)
SBP, Week 3, n=11 2.8  (11.07)
SBP, Week 4, n=6 -2.8  (9.79)
SBP, Week 5, n=3 -1.0  (9.54)
SBP, Week 6, n=3 -4.0  (3.00)
SBP, Week 7, n=3 -1.3  (5.69)
SBP, Week 8, n=2 12.0  (15.56)
SBP, Week 9, n=1 3.0 [1]   (NA)
SBP, Withdrawal, n=4 13.5  (13.96)
SBP, Follow Up, week 4, n=3 -1.0  (8.54)
SBP, Follow Up, week 12, n=3 9.0  (8.89)
SBP, Follow Up, week 24, n=3 2.7  (10.07)
DBP, Week 1, n=38 -0.5  (8.81)
DBP, Week 2, n=30 -2.1  (8.04)
DBP, Week 3, n=11 -1.6  (7.98)
DBP, Week 4, n=6 -1.7  (8.04)
DBP, Week 5, n=3 -7.3  (9.87)
DBP, Week 6, n=3 -3.3  (7.64)
DBP, Week 7, n=3 -9.0  (7.00)
DBP, Week 8, n=2 6.0  (14.14)
DBP, Week 9, n=1 -10.0 [1]   (NA)
DBP, Withdrawal, n=4 5.8  (12.09)
DBP, FU Week 4, n=3 0.3  (5.51)
DBP, FU Week 12, n=3 4.0  (10.39)
DBP, FU Week 24, n=3 -0.3  (1.53)
[1]
Forty subjects in Part1 achieved platelet counts >=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
30.Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
Hide Description Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time Frame Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
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Hide Analysis Population Description
SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP, Antiviral Baseline, n=40 0.2  (13.99)
SBP, Week 1, n=40 -5.9  (10.37)
SBP, Week 2, n=40 -8.7  (13.35)
SBP, Week 4, n=37 -5.2  (13.69)
SBP, Week 6, n=36 -3.9  (13.09)
SBP, Week 8, n=36 -6.0  (14.53)
SBP, Week 12, n=36 -5.7  (13.08)
SBP, Week 16, n=36 -5.5  (16.52)
SBP, Week 20, n=36 -4.4  (15.18)
SBP, Week 24, n=36 -2.1  (15.70)
SBP, Week 28, n=34 -6.3  (15.76)
SBP, Week 32, n=34 -5.2  (17.60)
SBP, Week 36, n=34 -5.6  (15.36)
SBP, Week 40, n=33 -5.1  (13.47)
SBP, Week 44, n=31 -4.6  (16.60)
SBP, Week 48, n=31 -2.9  (12.37)
SBP, withdrawal, n=10 0.5  (17.26)
DBP, Antiviral Baseline, n=40 -0.4  (6.35)
DBP, Week 1, n=40 -3.5  (9.28)
DBP, Week 2, n=40 -4.0  (9.59)
DBP, Week 4, n=37 -3.5  (9.81)
DBP, Week 6, n=36 -3.9  (9.16)
DBP, Week 8, n=36 -6.0  (9.62)
DBP, Week 12, n=36 -5.9  (10.07)
DBP, Week 16, n=36 -4.7  (9.94)
DBP, Week 20, n=36 -5.7  (11.17)
DBP, Week 24, n=36 -4.5  (12.34)
DBP, Week 28, n=34 -7.9  (11.48)
DBP, Week 32, n=34 -7.1  (11.97)
DBP, Week 36, n=34 -5.4  (9.96)
DBP, Week 40, n=33 -6.8  (9.69)
DBP, Week 44, n=31 -5.8  (12.18)
DBP, Week 48, n=31 -3.8  (8.36)
DBP, withdrawal, n=10 -2.4  (8.24)
31.Secondary Outcome
Title Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
Hide Description Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.
Time Frame FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP, FU Baseline, n=40 126.5  (11.30)
SBP, FU Week 4, n=40 125.4  (11.74)
SBP, Week 12, n=40 126.7  (10.86)
SBP, Week 24, n=37 128.4  (12.68)
DBP, FU Baseline, n=40 73.8  (8.85)
DBP, FU Week 4, n=40 74.3  (8.91)
DBP, FU Week 12, n=40 76.2  (9.40)
DBP, FU Week 24, n=37 75.7  (9.48)
32.Secondary Outcome
Title Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Hide Description The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time Frame Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
Week 1, n=38 0.1  (7.07)
Week 2, n=30 -0.1  (7.42)
Week 3, n=11 0.1  (4.50)
Week 4, n=6 2.8  (4.07)
Week 5, n=3 0.3  (7.37)
Week 6, n=3 2.0  (5.29)
Week 7, n=3 3.0  (7.00)
Week 8, n=2 -1.0  (5.66)
Week 9, n=1 -4.0 [1]   (NA)
Withdrawal, n=4 2.8  (8.30)
FU Week 4, n=3 0.7  (12.66)
FU Week 12, n=3 3.7  (9.07)
FU Week 24, n=3 2.0  (9.54)
[1]
Forty subjects in Part1 achieved platelet counts >=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
33.Secondary Outcome
Title Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Hide Description The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.
Time Frame Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: bpm
Antiviral Baseline, n=40 0.4  (7.56)
Week 1, n=40 -3.5  (9.51)
Week 2, n=40 1.0  (9.57)
Week 4, n=37 3.9  (9.29)
Week 6, n=36 5.9  (9.78)
Week 8, n=36 4.7  (10.60)
Week 12, n=36 5.8  (10.34)
Week 16, n=36 6.2  (9.91)
Week 20, n=36 4.5  (10.54)
Week 24, n=36 4.5  (9.79)
Week 28, n=34 5.6  (9.85)
Week 32, n=34 3.6  (8.80)
Week 36, n=34 4.7  (9.07)
Week 40, n=33 5.2  (8.20)
Week 44, n=31 5.2  (7.11)
Week 48, n=31 3.6  (7.18)
Withdrawal, n=10 5.1  (11.86)
34.Secondary Outcome
Title Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2
Hide Description The heart rate was measured in participants at the indicated time points.
Time Frame FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: bpm
FU Baseline, n=40 78.3  (8.77)
FU Week 4, n=40 79.5  (9.38)
FU Week 12, n=40 74.0  (8.64)
FU Week 24, n=37 74.6  (9.58)
35.Secondary Outcome
Title Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Hide Description The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time Frame Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Kilogram (kg)
Week 1, n=38 0.09  (0.807)
Week 2, n=30 0.05  (1.239)
Week 3, n=11 0.75  (1.196)
Week 4, n=6 1.15  (0.931)
Week 5, n=3 1.00  (1.400)
Week 6, n=3 1.03  (0.723)
Week 7, n=3 0.57  (1.159)
Week 8, n=2 0.15  (1.909)
Week 9, n=1 0.20 [1]   (NA)
Withdrawal, n=4 0.30  (1.519)
FU Week 4, n=3 0.90  (1.212)
FU Week 12, n=3 0.93  (3.009)
FU Week 24, n=3 1.17  (2.894)
[1]
Forty subjects in Part1 achieved platelet counts >=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
36.Secondary Outcome
Title Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Hide Description The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time Frame Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: kg
Antivital Baseline, n=40 0.04  (1.336)
Week 1, n=40 -0.95  (1.131)
Week 2, n=40 -1.14  (1.314)
Week 4, n=37 -1.04  (1.060)
Week 6, n=36 -1.05  (1.344)
Week 8, n=36 -1.28  (1.581)
Week 12, n=36 -1.73  (1.887)
Week 16, n=36 -2.13  (2.175)
Week 20, n=36 -2.49  (2.265)
Week 24, n=36 -3.11  (2.488)
Week 28, n=34 -3.00  (3.104)
Week 32, n=34 -3.16  (3.100)
Week 36, n=34 -3.43  (3.188)
Week 40, n=33 -3.61  (3.000)
Week 44, n=31 -3.39  (3.018)
Week 48, n=31 -3.76  (2.950)
Withdrawal, n=10 -3.04  (3.584)
37.Secondary Outcome
Title Mean Weight at the Indicated Time Points During Follow-up Period After Part 2
Hide Description The weight of participants was recorded at the indicated time points.
Time Frame FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: kg
FU Baseline, n=40 55.77  (11.403)
FU Week 4, n=40 56.37  (11.627)
FU Week 12, n=40 57.05  (11.841)
FU Week 24, n=37 57.84  (12.478)
38.Secondary Outcome
Title Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Hide Description The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time Frame Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Degrees centigrade
Week 1, n=38 -0.04  (0.439)
Week 2, n=30 0.03  (0.445)
Week 3, n=11 0.06  (0.284)
Week 4, n=6 0.07  (0.367)
Week 5, n=3 -0.07  (0.153)
Week 6, n=3 -0.10  (0.173)
Week 7, n=3 -0.40  (0.100)
Week 8, n=2 -0.50  (0.141)
Week 9, n=1 -1.10 [1]   (NA)
Withdrawal, n=4 -0.18  (0.171)
FU Week 4, n=3 0.07  (0.153)
FU Week 12, n=3 -0.23  (0.493)
FU Week 24, n=3 -0.17  (0.306)
[1]
Forty subjects in Part1 achieved platelet counts >=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
39.Secondary Outcome
Title Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Hide Description The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time Frame Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: Degrees centigrade
Antiviral Baseline, n=41 0.08  (0.662)
Week 1, n=40 0.09  (0.398)
Week 2, n=40 0.17  (0.459)
Week 4, n=37 0.16  (0.439)
Week 6, n=36 0.19  (0.499)
Week 8, n=36 0.22  (0.426)
Week 12, n=36 0.28  (0.440)
Week 16, n=36 0.22  (0.392)
Week 20, n=36 0.20  (0.386)
Week 24, n=36 0.26  (0.422)
Week 28, n=34 0.27  (0.424)
Week 32, n=34 0.21  (0.435)
Week 36, n=34 0.22  (0.462)
Week 40, n=33 0.26  (0.374)
Week 44, n=31 0.20  (0.492)
Week 48, n=31 0.15  (0.498)
Withdrawal, n=10 0.38  (0.724)
40.Secondary Outcome
Title Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2
Hide Description The Body temperature of participants was recorded at the indicated time points..
Time Frame FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: Degrees centigrade
FU Baseline, n=40 36.44  (0.417)
FU Week 4, n=40 36.37  (0.360)
FU Week 12, n=40 36.29  (0.350)
FU Week 24, n=37 36.90  (0.377)
41.Secondary Outcome
Title Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Hide Description The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time Frame Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: kilogram per meters squared (kg/m^2)
Week 1, n=38 0.03  (0.302)
Week 2, n=30 0.02  (0.457)
Week 3, n=11 0.26  (0.415)
Week 4, n=6 0.39  (0.325)
Week 5, n=3 0.36  (0.504)
Week 6, n=3 0.36  (0.248)
Week 7, n=3 0.20  (0.417)
Week 8, n=2 0.04  (0.704)
Week 9, n=1 0.08 [1]   (NA)
Withdrawal, n=4 0.09  (0.572)
FU, Week 4, n=3 0.34  (0.432)
FU, Week 12, n=3 0.36  (1.084)
FU, Week 24, n=3 0.41  (1.042)
[1]
Forty subjects in Part1 achieved platelet counts >=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
42.Secondary Outcome
Title Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Hide Description The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time Frame Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Antiviral Baseline, n=40 0.01  (0.476)
Week 1, n=40 -0.37  (0.408)
Week 2, n=40 -0.44  (0.495)
Week 4, n=37 -0.41  (0.424)
Week 6, n=36 -0.42  (0.534)
Week 8, n=36 -0.51  (0.624)
Week 12, n=36 -0.70  (0.723)
Week 16, n=36 -0.86  (0.844)
Week 20, n=36 -1.01  (0.891)
Week 24, n=36 -1.25  (0.965)
Week 28, n=34 -1.21  (1.212)
Week 32, n=34 -1.28  (1.228)
Week 36, n=34 -1.38  (1.264)
Week 40, n=33 -1.45  (1.200)
Week 44, n=31 -1.36  (1.174)
Week 48, n=31 -1.50  (1.146)
Withdrawal, n=10 -1.23  (1.529)
43.Secondary Outcome
Title Mean BMI at the Indicated Time Points During Follow-up Period After Part 2
Hide Description The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.
Time Frame FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: kilogram per meters squared (kg/m^2)
FU Baseline, n=40 21.89  (3.486)
FU Week 4, n=40 22.11  (3.474)
FU Week 12, n=40 22.37  (3.531)
FU Week 24, n=37 22.54  (3.521)
44.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Hide Description Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time Frame From Baseline up to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Albumin: Any Grade Increase 5
Albumin: Increase to G1 5
Albumin: Increase to G2 0
Albumin: Increase to G3 0
Albumin: Increase to G4 0
ALP: Any Grade Increase 4
ALP: Increase to G1 2
ALP: Increase to G2 2
ALP: Increase to G3 0
ALP: Increase to G4 0
ALT: Any Grade Increase 5
ALT: Increase to G1 1
ALT: Increase to G2 2
ALT: Increase to G3 2
ALT: Increase to G4 0
AST:Any Grade Increase 9
AST:Increase to G1 2
AST:Increase to G2 5
AST:Increase to G3 2
AST:Increase to G4 0
Total Bilirubin:Any Grade Increase 8
Total Bilirubin:Increase to G1 6
Total Bilirubin:Increase to G2 2
Total Bilirubin:Increase to G3 0
Total Bilirubin:Increase to G4 0
Calcium:Any Grade Increase 5
Calcium:Increase to G1 5
Calcium:Increase to G2 0
Calcium:Increase to G3 0
Calcium:Increase to G4 0
Creatinine:Any Grade Increase 1
Creatinine:Increase to G1 1
Creatinine:Increase to G2 0
Creatinine:Increase to G3 0
Creatinine:Increase to G4 0
Potassium:Any Grade Increase 3
Potassium:Increase to G1 3
Potassium:Increase to G2 0
Potassium:Increase to G3 0
Potassium:Increase to G4 0
Sodium:Any Grade Increase 2
Sodium:Increase to G1 2
Sodium:Increase to G2 0
Sodium:Increase to G3 0
Sodium:Increase to G4 0
Uric Acid:Any Grade Increase 6
Uric acid:Increase to G1 5
Uric acid:Increase to G2 1
Uric acid:Increase to G3 0
Uric acid:Increase to G4 0
45.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Hide Description Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time Frame From Antiviral Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
Albumin:Any Grade Increase 18
Albumin:Increase to G1 15
Albumin:Increase to G2 3
Albumin:Increase to G3 0
Albumin:Increase to G4 0
ALP:Any Grade Increase 3
ALP:Increase to G1 3
ALP:Increase to G2 0
ALP:Increase to G3 0
ALP:Increase to G4 0
ALT:Any Grade Increase 14
ALT:Increase to G1 1
ALT:Increase to G2 6
ALT:Increase to G3 6
ALT:Increase to G4 1
AST:Any Grade Increase 22
AST:Increase to G1 4
AST:Increase to G2 11
AST:Increase to G3 6
AST:Increase to G4 1
Total Bilirubin:Any Grade Increase 20
Total Bilirubin:Increase to G1 7
Total Bilirubin:Increase to G2 9
Total Bilirubin:Increase to G3 3
Total Bilirubin:Increase to G4 1
Calcium:Any Grade Increase 31
Calcium:Increase to G1 25
Calcium:Increase to G2 6
Calcium:Increase to G3 0
Calcium:Increase to G4 0
Creatinine:Any Grade Increase 3
Creatinine:Increase to G1 2
Creatinine:Increase to G2 1
Creatinine:Increase to G3 0
Creatinine:Increase to G4 0
Potassium:Any Grade Increase 8
Potassium:Increase to G1 8
Potassium:Increase to G2 0
Potassium:Increase to G3 0
Potassium:Increase to G4 0
Sodium:Any Grade Increase 7
Sodium:Increase to G1 7
Sodium:Increase to G2 0
Sodium:Increase to G3 0
Sodium:Increase to G4 0
Uric acid:Any Grade Increase 13
Uric acid:Increase to G1 9
Uric acid:Increase to G2 4
Uric acid:Increase to G3 0
Uric acid:Increase to G4 0
46.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Hide Description Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time Frame From FU Week 4 to FU Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Albumin:Any Grade Increase 3
Albumin:Increase to G1 2
Albumin:Increase to G2 1
Albumin:Increase to G3 0
Albumin:Increase to G4 0
ALP:Any Grade Increase 5
ALP:Increase to G1 4
ALP:Increase to G2 1
ALP:Increase to G3 0
ALP:Increase to G4 0
ALT:Any Grade Increase 9
ALT:Increase to G1 4
ALT:Increase to G2 4
ALT:Increase to G3 0
ALT:Increase to G4 1
AST:Any Grade Increase 10
AST:Increase to G1 3
AST:Increase to G2 6
AST:Increase to G3 0
AST:Increase to G4 1
Total Bilirubin:Any Grade Increase 4
Total Bilirubin:Increase to G1 2
Total Bilirubin:Increase to G2 2
Total Bilirubin:Increase to G3 0
Total Bilirubin:Increase to G4 0
Calcium:Any Grade Increase 2
Calcium:Increase to G1 2
Calcium:Increase to G2 0
Calcium:Increase to G3 0
Calcium:Increase to G4 0
Calcium serum high: Any Grade Increase 0
Calcium, serum high: Increase to G1 0
Calcium, serum high: Increase to G2 0
Calcium, serum high: Increase to G3 0
Calcium, serum high: Increase to G4 0
Calcium serum low: Any Grade Increase 2
Calcium, serum low: Increase to G1 2
Calcium, serum low: Increase to G2 0
Calcium, serum low: Increase to G3 0
Calcium, serum low: Increase to G4 0
Creatinine: Any Grade Increase 1
Creatinine: Increase to G1 1
Creatinine: Increase to G2 0
Creatinine: Increase to G3 0
Creatinine: Increase to G4 0
Potassium:Any Grade Increase 3
Potassium:Increase to G1 3
Potassium:Increase to G2 0
Potassium:Increase to G3 0
Potassium:Increase to G4 0
Potassium, serum high:Any Grade Increase 0
Potassium, serum high:Increase to G1 0
Potassium, serum high:Increase to G2 0
Potassium, serum high:Increase to G3 0
Potassium, serum high:Increase to G4 0
Potassium, serum low:Any Grade Increase 3
Potassium, serum low:Increase to G1 3
Potassium, serum low:Increase to G2 0
Potassium, serum low:Increase to G3 0
Potassium, serum low:Increase to G4 0
Sodium:Any Grade Increase 1
Sodium:Increase to G1 1
Sodium:Increase to G2 0
Sodium:Increase to G3 0
Sodium:Increase to G4 0
Sodium, serum high:Any Grade Increase 1
Sodium, serum high:Increase to G1 1
Sodium, serum high:Increase to G2 0
Sodium, serum high:Increase to G3 0
Sodium, serum high:Increase to G4 0
Sodium, serum low:Any Grade Increase 0
Sodium, serum low:Increase to G1 0
Sodium, serum low:Increase to G2 0
Sodium, serum low:Increase to G3 0
Sodium, serum low:Increase to G4 0
Uric acid:Any Grade Increase 2
Uric acid:Increase to G1 2
Uric acid:Increase to G2 0
Uric acid:Increase to G3 0
Uric acid:Increase to G4 0
47.Secondary Outcome
Title Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Hide Description Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time Frame From Baseline up to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Hemoglobin:Any Grade Increase 1
Hemoglobin:Increase to G1 1
Hemoglobin:Increase to G2 0
Hemoglobin:Increase to G3 0
Hemoglobin:Increase to G4 0
Lymphocytes:Any Grade Increase 4
Lymphocytes:Increase to G1 1
Lymphocytes:Increase to G2 0
Lymphocytes:Increase to G3 3
Lymphocytes:Increase to G4 0
Total Neutrophils:Any Grade Increase 8
Total Neutrophils:Increase to G1 6
Total Neutrophils:Increase to G2 2
Total Neutrophils:Increase to G3 0
Total Neutrophils:Increase to G4 0
Platelet count:Any Grade Increase 0
Platelet count:Increase to G1 0
Platelet count:Increase to G2 0
Platelet count:Increase to G3 0
Platelet count:Increase to G4 0
White Blood Cell count:Any Grade Increase 7
White Blood Cell count:Increase to G1 7
White Blood Cell count:Increase to G2 0
White Blood Cell count:Increase to G3 0
White Blood Cell count:Increase to G4 0
48.Secondary Outcome
Title Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Hide Description Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time Frame From Antiviral Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
Hemoglobin:Any Grade Increase 38
Hemoglobin:Increase to G1 3
Hemoglobin:Increase to G2 11
Hemoglobin:Increase to G3 24
Hemoglobin:Increase to G4 0
Lymphocytes:Any Grade Increase 26
Lymphocytes:Increase to G1 0
Lymphocytes:Increase to G2 6
Lymphocytes:Increase to G3 12
Lymphocytes:Increase to G4 8
Total Neutrophils:Any Grade Increase 38
Total Neutrophils:Increase to G1 8
Total Neutrophils:Increase to G2 10
Total Neutrophils:Increase to G3 16
Total Neutrophils:Increase to G4 4
Platelet count:Any Grade Increase 5
Platelet count:Increase to G1 0
Platelet count:Increase to G2 0
Platelet count:Increase to G3 5
Platelet count:Increase to G4 0
White Blood Cell count:Any Grade Increase 38
White Blood Cell count:Increase to G1 10
White Blood Cell count:Increase to G2 18
White Blood Cell count:Increase to G3 9
White Blood Cell count:Increase to G4 1
49.Secondary Outcome
Title Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Hide Description Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time Frame From FU Week 4 to FU Week 24
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Hide Analysis Population Description
SP2 Population,
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Hemoglobin:Any Grade Increase 2
Hemoglobin:Increase to G1 2
Hemoglobin:Increase to G2 0
Hemoglobin:Increase to G3 0
Hemoglobin:Increase to G4 0
Lymphocytes:Any Grade Increase 2
Lymphocytes:Increase to G1 0
Lymphocytes:Increase to G2 2
Lymphocytes:Increase to G3 0
Lymphocytes:Increase to G4 0
Total Neutrophils:Any Grade Increase 7
Total Neutrophils:Increase to G1 3
Total Neutrophils:Increase to G2 4
Total Neutrophils:Increase to G3 0
Total Neutrophils:Increase to G4 0
Platelet count:Any Grade Increase 15
Platelet count:Increase to G1 0
Platelet count:Increase to G2 8
Platelet count:Increase to G3 7
Platelet count:Increase to G4 0
White Blood Cell count:Any Grade Increase 6
White Blood Cell count:Increase to G1 3
White Blood Cell count:Increase to G2 3
White Blood Cell count:Increase to G3 0
White Blood Cell count:Increase to G4 0
50.Secondary Outcome
Title Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Hide Description Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.
Time Frame Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24
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Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
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Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Screening, UB, (-), n=45 6
Screening, UB, Neg., n=45 39
Screening, UOB, 1+, n=45 4
Screening, UOB, 2+, n=45 1
Screening, UOB, 3+, n=45 1
Screening, UOB, (-), n=45 6
Screening, UOB, Neg., n=45 31
Screening, UOB, trace., n=45 2
Screening, UG, (-), n=45 7
Screening, UG, 0.5, n=45 1
Screening, UG, Neg., n=45 37
Screening, UK, (-), n=45 7
Screening, UK, Neg., n=45 38
Screening, pH, 5, n=45 1
Screening, pH, 5.5, n=45 9
Screening, pH, 6, n=45 9
Screening, pH, 6.5, n=45 12
Screening, pH, 7, n=45 9
Screening, pH, 7.5, n=45 5
Screening, UP, 1+., n=45 1
Screening, UP, (-), n=45 5
Screening, UP, Neg., n=45 35
Screening, UP, trace, n=45 4
Screening, UU, 1+, n=45 2
Screening, UU, (-), n=45 1
Screening, UU, 0.1, n=45 5
Screening, UU, 1, n=45 6
Screening, UU, 2, n=45 4
Screening, UU, trace, n=45 19
Screening, UU, normal, n=45 8
Screening, USG, 1.005, n=45 2
Screening, USG, 1.006, n=45 1
Screening, USG, 1.007, n=45 2
Screening, USG, 1.008, n=45 1
Screening, USG, 1.009, n=45 1
Screening, USG, 1.01, n=45 3
Screening, USG, 1.011, n=45 2
Screening, USG, 1.012, n=45 1
Screening, USG, 1.013, n=45 1
Screening, USG, 1.014, n=45 4
Screening, USG, 1.015, n=45 4
Screening, USG, 1.017, n=45 2
Screening, USG, 1.018, n=45 4
Screening, USG, 1.019, n=45 1
Screening, USG, 1.02, n=45 8
Screening, USG, 1.021, n=45 1
Screening, USG, 1.022, n=45 1
Screening, USG, 1.024, n=45 1
Screening, USG, 1.025, n=45 1
Screening, USG, 1.026, n=45 3
Screening, USG, 1.03, n=45 1
Baseline, UB, (-), n=45 6
Baseline, UB, Neg., n=45 39
Baseline, UOB, 1+, n=45 1
Baseline, UOB, 2+, n=45 1
Baseline, UOB, 3+, n=45 2
Baseline, UOB, (-), n=45 6
Baseline, UOB, Neg., n=45 32
Baseline, UOB, trace., n=45 3
Baseline, UG, 2+, n=45 1
Baseline, UG, (-), n=45 7
Baseline, UG, 0.1, n=45 1
Baseline, UG, 0.5, n=45 1
Baseline, UG, Neg., n=45 35
Baseline, UK, (-), n=45 7
Baseline, UK, Neg., n=45 38
Baseline, pH, 5, n=45 2
Baseline, pH, 5.5, n=45 8
Baseline, pH, 6, n=45 13
Baseline, pH, 6.5, n=45 11
Baseline, pH, 7, n=45 7
Baseline, pH, 7.5, n=45 3
Baseline, pH, 8, n=45 1
Baseline, UP, 1+., n=45 1
Baseline, UP, (-), n=45 5
Baseline, UP, Neg., n=45 36
Baseline, UP, trace, n=45 3
Baseline, UU, 1+, n=45 7
Baseline, UU, (-), n=45 1
Baseline, UU, 0.1, n=45 4
Baseline, UU, 1, n=45 10
Baseline, UU, 2, n=45 1
Baseline, UU, trace, n=45 15
Baseline, UU, normal, n=45 7
Baseline, USG, 1.003, n=45 1
Baseline, USG, 1.005, n=45 3
Baseline, USG, 1.006, n=45 1
Baseline, USG, 1.007, n=45 1
Baseline, USG, 1.009, n=45 1
Baseline, USG, 1.01, n=45 6
Baseline, USG, 1.011, n=45 2
Baseline, USG, 1.012, n=45 1
Baseline, USG, 1.013, n=45 2
Baseline, USG, 1.014, n=45 1
Baseline, USG, 1.015, n=45 2
Baseline, USG, 1.016, n=45 2
Baseline, USG, 1.017, n=45 1
Baseline, USG, 1.018, n=45 3
Baseline, USG, 1.019, n=45 2
Baseline, USG, 1.02, n=45 5
Baseline, USG, 1.021, n=45 3
Baseline, USG, 1.022, n=45 1
Baseline, USG, 1.023, n=45 1
Baseline, USG, 1.025, n=45 3
Baseline, USG, 1.028, n=45 2
Baseline, USG, 1.03, n=45 1
Week 1, UB, Neg, n=1 1
Week 1, UOB, Neg, n=1 1
Week 1, UG, Neg, n=1 1
Week 1, UK, Neg, n=1 1
Week 1, pH, 7.5, n=1 1
Week 1, UP, trace, n=1 1
Week 1, USG, 1.021, n=1 1
Week 1, UU, trace, n=1 1
Week 2, UB, Neg, n=3 3
Week 2, UOB, Neg, n=3 3
Week 2, UG, 0.25, n=3 1
Week 2, UG, Neg, n=3 2
Week 2, UK, Neg, n=3 3
Week 2, pH, 6, n=3 1
Week 2, pH, 6.5, n=3 2
Week 2, UP, Neg, n=3 3
Week 2, USG, 1.016, Neg, n=3 1
Week 2, USG, 1.019, n=3 1
Week 2, USG, 1.02, n=3 1
Week 2, UU, 0.1, n=3 1
Week 2, UU, trace, n=3 1
Week 2, UU, normal, n=3 1
Week 3, UB, Neg, n=2 2
Week 3, UOB, Neg, n=2 2
Week 3, UG, >=1.0, n=2 1
Week 3, UG, Neg, n=2 1
Week 3, UK, Neg, n=2 2
Week 3, pH, 6, n=2 1
Week 3, pH, 6.5, n=2 1
Week 3, UP, Neg, n=2 2
Week 3, USG, 1.015, n=2 1
Week 3, USG, 1.02, n=2 1
Week 3, UU, 0.1, n=2 1
Week 3, UU, 4, n=2 1
Week 4, UB, Neg, n=5 5
Week 4, UOB, Neg, n=5 5
Week 4, UG, >=1.0, n=5 1
Week 4, UG, Neg, n=5 4
Week 4, UK, Neg, n=5 5
Week 4, pH, 5.5, n=5 1
Week 4, pH, 6, n=5 2
Week 4, pH, 6.5, n=5 2
Week 4, UP, Neg, n=5 5
Week 4, USG, 1.015, n=5 1
Week 4, USG, 1.02, n=5 2
Week 4, USG, 1.025, n=5 1
Week 4, USG, 1.026, n=5 1
Week 4, UU, 1, n=5 2
Week 4, UU, 2, n=5 1
Week 4, UU, trace, n=5 2
Week 7, UB, Neg, n=1 1
Week 7, UOB, Neg, n=1 1
Week 7, UG, 0.5, n=1 1
Week 7, UK, Neg, n=1 1
Week 7, pH, 7, n=1 1
Week 7, UP, Neg, n=1 1
Week 7, USG, 1.02, n=1 1
Week 7, UU, 2, n=1 1
Week 8, UB, Neg, n=2 2
Week 8, UOB, Neg, n=2 1
Week 8, UOB, trace, n=2 1
Week 8, UG, 0.1 n=2 1
Week 8, UG, Neg, n=2 1
Week 8, UK, Neg, n=2 2
Week 8, pH, 6, n=2 2
Week 8, UP, Neg, n=2 2
Week 8, USG, 1.023, n=2 1
Week 8, USG, 1.025, n=2 1
Week 8, UU, 0.1, n=2 1
Week 8, UU, trace, n=2 1
Withdrawal, UB, Neg, n=4 4
Withdrawal, UOB, Neg, n=4 4
Withdrawal, UG, 0.5, n=4 1
Withdrawal, UG, Neg, n=4 3
Withdrawal, UK, Neg, n=4 4
Withdrawal, pH, 6, n=4 2
Withdrawal, pH, 6.5, n=4 1
Withdrawal, pH, 8, n=4 1
Withdrawal, UP, Neg, n=4 4
Withdrawal, USG, 1.008, n=4 1
Withdrawal, USG, 1.01, n=4 1
Withdrawal, USG, 1.018, n=4 1
Withdrawal, USG, 1.025, n=4 1
Withdrawal, UU, 1+, n=4 2
Withdrawal, UU, 0.1, n=4 1
Withdrawal, UU, 1, n=4 1
FU, Week 24, UB, Neg, n=3 3
FU Week 24, UOB, 1+, n=3 1
FU Week 24, UOB, Neg, n=3 2
FU Week 24, UG, Neg, n=3 3
FU Week 24, UK, Neg, n=3 3
FU Week 24, pH, 5.5, n=3 1
FU Week 24, pH, 6, n=3 1
FU Week 24, pH, 7, n=3 1
FU Week 24, UP, Neg, n=3 3
FU Week 24, USG, 1.004, n=3 1
FU Week 24, USG, 1.01, n=3 1
FU Week 24, USG, 1.02, n=3 1
FU Week 24, UU, 0.1, n=3 1
FU Week 24, UU, 1, n=3 1
FU Week 24, UU, trace, n=3 1
51.Secondary Outcome
Title Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Hide Description Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.
Time Frame Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Part 2
Hide Arm/Group Description:
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
Antiviral Baseline, UB, (-), n=41 5
Antiviral Baseline, UB, Neg., n=41 36
Antiviral Baseline, UOB, 1+, n=41 1
Antiviral Baseline, UOB, (-), n=41 5
Antiviral Baseline, UOB, Neg., n=41 33
Antiviral Baseline, UOB, trace., n=41 2
Antiviral Baseline, UG, 1+, n=41 1
Antiviral Baseline, UG, 2+, n=41 1
Antiviral Baseline, UG, (-), n=41 5
Antiviral Baseline, UG, 0.25, n=41 1
Antiviral Baseline, UG, 0.5, n=41 1
Antiviral Baseline, UG, >=1.0, n=41 1
Antiviral Baseline, UG, Neg., n=41 31
Antiviral Baseline, UK, (-), n=41 5
Antiviral Baseline, UK, Neg., n=41 35
Antiviral Baseline, UK, trace, n=41 1
Antiviral Baseline, pH, 5, n=41 1
Antiviral Baseline, pH, 5.5, n=41 6
Antiviral Baseline, pH, 6, n=41 11
Antiviral Baseline, pH, 6.5, n=41 12
Antiviral Baseline, pH, 7, n=41 6
Antiviral Baseline, pH, 7.5, n=41 4
Antiviral Baseline, pH, 8.5, n=41 1
Antiviral Baseline, UP, (-), n=41 5
Antiviral Baseline, UP, Neg, n=41 34
Antiviral Baseline, UP, trace, n=41 2
Antiviral Baseline, USG, 1.005, n=41 1
Antiviral Baseline, USG, 1.006, n=41 1
Antiviral Baseline, USG, 1.01, n=41 3
Antiviral Baseline, USG, 1.011, n=41 4
Antiviral Baseline, USG, 1.012, n=41 2
Antiviral Baseline, USG, 1.013, n=41 2
Antiviral Baseline, USG, 1.014, n=41 2
Antiviral Baseline, USG, 1.015, n=41 4
Antiviral Baseline, USG, 1.016, n=41 3
Antiviral Baseline, USG, 1.017, n=41 1
Antiviral Baseline, USG, 1.018, n=41 2
Antiviral Baseline, USG, 1.019, n=41 1
Antiviral Baseline, USG, 1.02, n=41 8
Antiviral Baseline, USG, 1.021, n=41 1
Antiviral Baseline, USG, 1.022, n=41 1
Antiviral Baseline, USG, 1.023, n=41 1
Antiviral Baseline, USG, 1.024, n=41 1
Antiviral Baseline, USG, 1.025, n=41 1
Antiviral Baseline, USG, 1.026, n=41 1
Antiviral Baseline, USG, 1.027, n=41 1
Antiviral Baseline, UU, 1+, n=41 3
Antiviral Baseline, UU, 0.1, n=41 3
Antiviral Baseline, UU, 1, n=41 6
Antiviral Baseline, UU, 2, n=41 2
Antiviral Baseline, UU, 4, n=41 2
Antiviral Baseline, UU, Neg, n=41 1
Antiviral Baseline, UU, trace, n=41 16
Antiviral Baseline, UU, normal, n=41 8
Week 4, UB, (-), n=37 6
Week 4, UB, Neg, n=37 31
Week 4, UOB, 2+, n=37 1
Week 4, UOB, (-), n=37 6
Week 4, UOB, Neg, n=37 30
Week 4, UG, (-), n=37 6
Week 4, UG, 0.1, n=37 1
Week 4, UG, Neg, n=37 30
Week 4, UK, (-), n=37 6
Week 4, UK, Neg, n=37 31
Week 4, pH, 5, n=37 1
Week 4, pH, 5.5, n=37 4
Week 4, pH, 6, n=37 9
Week 4, pH, 6.5, n=37 12
Week 4, pH, 7, n=37 6
Week 4, pH, 7.5, n=37 4
Week 4, pH, 8, n=37 1
Week 4, UP, (-), n=37 4
Week 4, UP, Neg, n=37 28
Week 4, UP, trace, n=37 5
Week 4, USG, 1.004, n=37 1
Week 4, USG, 1.005, n=37 3
Week 4, USG, 1.006, n=37 3
Week 4, USG, 1.008, n=37 1
Week 4, USG, 1.01, n=37 2
Week 4, USG, 1.011, n=37 2
Week 4, USG, 1.012, n=37 1
Week 4, USG, 1.013, n=37 2
Week 4, USG, 1.014, n=37 1
Week 4, USG, 1.015, n=37 4
Week 4, USG, 1.016, n=37 1
Week 4, USG, 1.017, n=37 2
Week 4, USG, 1.019, n=37 1
Week 4, USG, 1.02, n=37 6
Week 4, USG, 1.021, n=37 2
Week 4, USG, 1.022, n=37 2
Week 4, USG, 1.025, n=37 3
Week 4, UU, 1+, n=37 3
Week 4, UU, 0.1, n=37 2
Week 4, UU, 1, n=37 7
Week 4, UU, 2, n=37 2
Week 4, UU, 4, n=37 1
Week 4, UU, 8, n=37 1
Week 4, UU, Neg, n=37 2
Week 4, UU, trace, n=37 15
Week 4, UU, normal, n=37 4
Week 8, UB, (-), n=36 4
Week 8, UB, 2, n=36 1
Week 8, UB, Neg, n=36 31
Week 8, UOB, 1+, n=36 1
Week 8, UOB, 2+, n=36 1
Week 8, UOB, (-), n=36 4
Week 8, UOB, Neg, n=36 30
Week 8, UG, 1+, n=36 1
Week 8, UG, (-), n=36 5
Week 8, UG, >=1.0, n=36 1
Week 8, UG, Neg, n=36 29
Week 8, UK, (-), n=36 5
Week 8, UK, Neg, n=36 30
Week 8, UK, trace, n=36 1
Week 8, pH, 5, n=36 1
Week 8, pH, 5.5, n=36 4
Week 8, pH, 6, n=36 7
Week 8, pH, 6.5, n=36 13
Week 8, pH, 7, n=36 7
Week 8, pH, 7.5, n=36 3
Week 8, pH, 8, n=36 1
Week 8, UP, 1+, n=36 2
Week 8, UP, (-), n=36 2
Week 8, UP, Neg, n=36 30
Week 8, UP, trace, n=36 2
Week 8, USG, 1.001, n=36 1
Week 8, USG, 1.003, n=36 1
Week 8, USG, 1.004, n=36 1
Week 8, USG, 1.005, n=36 2
Week 8, USG, 1.008, n=36 4
Week 8, USG, 1.01, n=36 3
Week 8, USG, 1.012, n=36 1
Week 8, USG, 1.013, n=36 3
Week 8, USG, 1.014, n=36 1
Week 8, USG, 1.015, n=36 2
Week 8, USG, 1.016, n=36 3
Week 8, USG, 1.018, n=36 3
Week 8, USG, 1.019, n=36 1
Week 8, USG, 1.02, n=36 2
Week 8, USG, 1.023, n=36 2
Week 8, USG, 1.025, n=36 4
Week 8, USG, <=1.005, n=36 1
Week 8, USG, >=1.030, n=36 1
Week 8, UU, 1+, n=36 5
Week 8, UU, (-), n=36 1
Week 8, UU, 0.1, n=36 2
Week 8, UU, 1, n=36 7
Week 8, UU, 2, n=36 1
Week 8, UU, 4, n=36 3
Week 8, UU, Neg, n=36 1
Week 8, UU, trace, n=36 11
Week 8, UU, normal, n=36 5
Week 12, UB, (-), n=36 5
Week 12, UB, Neg, n=36 31
Week 12, UOB, (-), n=36 5
Week 12, UOB, Neg, n=36 31
Week 12, UG, (-), n=36 5
Week 12, UG, 0.25, n=36 1
Week 12, UG, Neg, n=36 30
Week 12, UK, (-), n=36 5
Week 12, UK, 0, n=36 1
Week 12, UK, Neg, n=36 30
Week 12, pH, 5, n=36 2
Week 12, pH, 5.5, n=36 2
Week 12, pH, 6, n=36 9
Week 12, pH, 6.5, n=36 12
Week 12, pH, 7, n=36 7
Week 12, pH, 7.5, n=36 4
Week 12, UP, 1+, n=36 2
Week 12, UP, (-), n=36 3
Week 12, UP, Neg, n=36 26
Week 12, UP, trace, n=36 5
Week 12, USG, 1.005, n=36 2
Week 12, USG, 1.006, n=36 3
Week 12, USG, 1.007, n=36 1
Week 12, USG, 1.008, n=36 1
Week 12, USG, 1.009, n=36 1
Week 12, USG, 1.01, n=36 1
Week 12, USG, 1.012, n=36 2
Week 12, USG, 1.014, n=36 2
Week 12, USG, 1.015, n=36 7
Week 12, USG, 1.016, n=36 1
Week 12, USG, 1.017, n=36 1
Week 12, USG, 1.018, n=36 2
Week 12, USG, 1.019, n=36 2
Week 12, USG, 1.02, n=36 5
Week 12, USG, 1.021, n=36 2
Week 12, USG, 1.022, n=36 2
Week 12, USG, 1.026, n=36 1
Week 12, UU, 1+, n=36 1
Week 12, UU, 0.1, n=36 3
Week 12, UU, 1, n=36 4
Week 12, UU, 2, n=36 3
Week 12, UU, 4, n=36 2
Week 12, UU, Neg, n=36 2
Week 12, UU, trace, n=36 15
Week 12, UU, normal, n=36 6
Week 16, UB, (-), n=36 4
Week 16, UB, Neg, n=36 32
Week 16, UOB, 1+, n=36 2
Week 16, UOB, 2+, n=36 2
Week 16, UOB, 3+, n=36 1
Week 16, UOB, (-), n=36 4
Week 16, UOB, Neg, n=36 27
Week 16, UG, (-), n=36 4
Week 16, UG, 0.25, n=36 1
Week 16, UG, Neg, n=36 31
Week 16, UK, (-), n=36 4
Week 16, UK, Neg, n=36 31
Week 16, UK, trace, n=36 1
Week 16, pH, 5, n=36 1
Week 16, pH, 5.5, n=36 3
Week 16, pH, 6, n=36 12
Week 16, pH, 6.5, n=36 9
Week 16, pH, 7, n=36 8
Week 16, pH, 7.5, n=36 3
Week 16, UP, 1+, n=36 1
Week 16, UP, (-), n=36 3
Week 16, UP, Neg, n=36 30
Week 16, UP, trace, n=36 2
Week 16, USG, 1.005, n=36 2
Week 16, USG, 1.006, n=36 1
Week 16, USG, 1.007, n=36 1
Week 16, USG, 1.008, n=36 2
Week 16, USG, 1.009, n=36 1
Week 16, USG, 1.01, n=36 3
Week 16, USG, 1.014, n=36 1
Week 16, USG, 1.015, n=36 7
Week 16, USG, 1.016, n=36 2
Week 16, USG, 1.017, n=36 1
Week 16, USG, 1.018, n=36 2
Week 16, USG, 1.019, n=36 4
Week 16, USG, 1.02, n=36 3
Week 16, USG, 1.021, n=36 1
Week 16, USG, 1.022, n=36 2
Week 16, USG, 1.023, n=36 1
Week 16, USG, 1.025, n=36 1
Week 16, USG, 1.027, n=36 1
Week 16, UU, 1+, n=36 5
Week 16, UU, 2+, n=36 1
Week 16, UU, 0.1, n=36 3
Week 16, UU, 1, n=36 7
Week 16, UU, 4, n=36 2
Week 16, UU, Neg, n=36 3
Week 16, UU, trace, n=36 11
Week 16, UU, normal, n=36 4
Week 20, UB, (-), n=36 2
Week 20, UB, Neg, n=36 34
Week 20, UOB, 1+, n=36 1
Week 20, UOB, (-), n=36 2
Week 20, UOB, Neg, n=36 33
Week 20, UG, (-), n=36 2
Week 20, UG, Neg, n=36 33
Week 20, UG, trace, n=36 1
Week 20, UK, (-), n=36 2
Week 20, UK, Neg, n=36 34
Week 20, pH, 5, n=36 4
Week 20, pH, 5.5, n=36 1
Week 20, pH, 6, n=36 10
Week 20, pH, 6.5, n=36 8
Week 20, pH, 7, n=36 6
Week 20, pH, 7.5, n=36 7
Week 20, UP, 1+, n=36 2
Week 20, UP, (-), n=36 2
Week 20, UP, Neg, n=36 30
Week 20, UP, trace, n=36 2
Week 20, USG, 1.004, n=36 1
Week 20, USG, 1.005, n=36 2
Week 20, USG, 1.006, n=36 1
Week 20, USG, 1.007, n=36 2
Week 20, USG, 1.009, n=36 3
Week 20, USG, 1.01, n=36 3
Week 20, USG, 1.013, n=36 3
Week 20, USG, 1.014, n=36 2
Week 20, USG, 1.015, n=36 2
Week 20, USG, 1.016, n=36 2
Week 20, USG, 1.017, n=36 2
Week 20, USG, 1.018, n=36 3
Week 20, USG, 1.019, n=36 1
Week 20, USG, 1.02, n=36 2
Week 20, USG, 1.021, n=36 2
Week 20, USG, 1.025, n=36 3
Week 20, USG, 1.029, n=36 1
Week 20, USG, <=1.005, n=36 1
Week 20, UU, 1+, n=36 3
Week 20, UU, 2+, n=36 1
Week 20, UU, 0.1, n=36 2
Week 20, UU, 1, n=36 7
Week 20, UU, 4, n=36 1
Week 20, UU, 8, n=36 2
Week 20, UU, Neg, n=36 2
Week 20, UU, trace, n=36 13
Week 20, UU, normal, n=36 5
Week 24, UB, (-), n=36 2
Week 24, UB, Neg, n=36 34
Week 24, UOB, 1+, n=36 2
Week 24, UOB, 3+, n=36 1
Week 24, UOB, (-), n=36 2
Week 24, UOB, Neg, n=36 30
Week 24, UOB, trace, n=36 1
Week 24, UG, (-), n=36 2
Week 24, UG, 0.1, n=36 1
Week 24, UG, Neg, n=36 33
Week 24, UK, (-), n=36 2
Week 24, UK, Neg, n=36 33
Week 24, UK, trace, n=36 1
Week 24, pH, 5, n=36 2
Week 24, pH, 5.5, n=36 3
Week 24, pH, 6, n=36 9
Week 24, pH, 6.5, n=36 12
Week 24, pH, 7, n=36 6
Week 24, pH, 7.5, n=36 3
Week 24, pH, 8.5, n=36 1
Week 24, UP, (-), n=36 2
Week 24, UP, Neg, n=36 28
Week 24, UP, trace, n=36 6
Week 24, USG, 1.008, n=36 1
Week 24, USG, 1.009, n=36 3
Week 24, USG, 1.01, n=36 3
Week 24, USG, 1.011, n=36 4
Week 24, USG, 1.012, n=36 2
Week 24, USG, 1.013, n=36 1
Week 24, USG, 1.014, n=36 2
Week 24, USG, 1.015, n=36 7
Week 24, USG, 1.016, n=36 1
Week 24, USG, 1.017, n=36 1
Week 24, USG, 1.018, n=36 1
Week 24, USG, 1.019, n=36 2
Week 24, USG, 1.021, n=36 2
Week 24, USG, 1.022, n=36 1
Week 24, USG, 1.023, n=36 1
Week 24, USG, 1.025, n=36 2
Week 24, USG, 1.03, n=36 1
Week 24, USG, <=1.005, n=36 1
Week 24, UU, 1+, n=36 2
Week 24, UU, 3+, n=36 1
Week 24, UU, 0.1, n=36 2
Week 24, UU, 1, n=36 8
Week 24, UU, 2, n=36 2
Week 24, UU, 4, n=36 1
Week 24, UU, Neg, n=36 2
Week 24, UU, trace, n=36 13
Week 24, UU, normal, n=36 5
Week 28, UB, 1+, n=34 1
Week 28, UB, (-), n=34 1
Week 28, UB, Neg, n=34 32
Week 28, UOB, 1+, n=34 1
Week 28, UOB, (-), n=34 1
Week 28, UOB, Neg, n=34 31
Week 28, UOB, trace, n=34 1
Week 28, UG, (-), n=34 1
Week 28, UG, 0.5, n=34 1
Week 28, UG, Neg, n=34 32
Week 28, UK, (-), n=34 1
Week 28, UK, Neg, n=34 32
Week 28, UK, trace, n=34 1
Week 28, pH, 5.5, n=34 1
Week 28, pH, 6, n=34 12
Week 28, pH, 6.5, n=34 11
Week 28, pH, 7, n=34 6
Week 28, pH, 7.5, n=34 3
Week 28, pH, 8, n=34 1
Week 28, UP, 1+, n=34 1
Week 28, UP, Neg, n=34 27
Week 28, UP, trace, n=34 6
Week 28, USG, 1.005, n=34 3
Week 28, USG, 1.007, n=34 2
Week 28, USG, 1.008, n=34 1
Week 28, USG, 1.009, n=34 2
Week 28, USG, 1.011, n=34 1
Week 28, USG, 1.012, n=34 2
Week 28, USG, 1.013, n=34 1
Week 28, USG, 1.015, n=34 2
Week 28, USG, 1.016, n=34 1
Week 28, USG, 1.017, n=34 2
Week 28, USG, 1.018, n=34 1
Week 28, USG, 1.019, n=34 2
Week 28, USG, 1.02, n=34 3
Week 28, USG, 1.022, n=34 1
Week 28, USG, 1.023, n=34 2
Week 28, USG, 1.024, n=34 2
Week 28, USG, 1.025, n=34 4
Week 28, USG, 1.027, n=34 1
Week 28, USG, <=1.005, n=34 1
Week 28, UU, 1+, n=34 4
Week 28, UU, 0.1, n=34 3
Week 28, UU, 1, n=34 6
Week 28, UU, 2, n=34 2
Week 28, UU, 4, n=34 3
Week 28, UU, Neg, n=34 1
Week 28, UU, trace, n=34 11
Week 28, UU, normal, n=34 4
Week 32, UB, (-), n=34 1
Week 32, UB, Neg, n=34 33
Week 32, UOB, 1+, n=34 1
Week 32, UOB, (-), n=34 1
Week 32, UOB, Neg, n=34 32
Week 32, UG, (-), n=34 1
Week 32, UG, Neg, n=34 33
Week 32, UK, (-), n=34 1
Week 32, UK, Neg, n=34 32
Week 32, UK, trace, n=34 1
Week 32, pH, 5, n=34 1
Week 32, pH, 5.5, n=34 2
Week 32, pH, 6, n=34 14
Week 32, pH, 6.5, n=34 8
Week 32, pH, 7, n=34 8
Week 32, pH, 7.5, n=34 1
Week 32, UP, (-), n=34 1
Week 32, UP, Neg, n=34 29
Week 32, UP, trace, n=34 4
Week 32, USG, 1.005, n=34 2
Week 32, USG, 1.006, n=34 1
Week 32, USG, 1.007, n=34 1
Week 32, USG, 1.01, n=34 4
Week 32, USG, 1.011, n=34 1
Week 32, USG, 1.012, n=34 1
Week 32, USG, 1.014, n=34 1
Week 32, USG, 1.015, n=34 4
Week 32, USG, 1.016, n=34 3
Week 32, USG, 1.018, n=34 2
Week 32, USG, 1.019, n=34 1
Week 32, USG, 1.02, n=34 6
Week 32, USG, 1.021, n=34 3
Week 32, USG, 1.022, n=34 3
Week 32, USG, 1.024, n=34 1
Week 32, UU, 1+, n=34 3
Week 32, UU, 0.1, n=34 2
Week 32, UU, 1, n=34 7
Week 32, UU, 3, n=34 1
Week 32, UU, 4, n=34 1
Week 32, UU, 8, n=34 1
Week 32, UU, Neg, n=34 1
Week 32, UU, trace, n=34 12
Week 32, UU, normal, n=34 6
Week 36, UB, 1+, n=34 1
Week 36, UB, (-), n=34 1
Week 36, UB, Neg, n=34 32
Week 36, UOB, 2+, n=34 2
Week 36, UOB, (-), n=34 1
Week 36, UOB, Neg, n=34 31
Week 36, UG, (-), n=34 1
Week 36, UG, Neg, n=34 33
Week 36, UK, 1+, n=34 1
Week 36, UK, (-), n=34 1
Week 36, UK, Neg, n=34 32
Week 36, pH, 5, n=34 1
Week 36, pH, 5.5, n=34 3
Week 36, pH, 6, n=34 9
Week 36, pH, 6.5, n=34 7
Week 36, pH, 7, n=34 10
Week 36, pH, 7.5, n=34 4
Week 36, UP, 1+, n=34 1
Week 36, UP, (-), n=34 1
Week 36, UP, Neg, n=34 30
Week 36, UP, trace, n=34 2
Week 36, USG, 1.005, n=34 2
Week 36, USG, 1.007, n=34 1
Week 36, USG, 1.008, n=34 2
Week 36, USG, 1.009, n=34 2
Week 36, USG, 1.01, n=34 2
Week 36, USG, 1.011, n=34 1
Week 36, USG, 1.012, n=34 2
Week 36, USG, 1.013, n=34 3
Week 36, USG, 1.015, n=34 3
Week 36, USG, 1.016, n=34 2
Week 36, USG, 1.018, n=34 2
Week 36, USG, 1.02, n=34 4
Week 36, USG, 1.021, n=34 4
Week 36, USG, 1.023, n=34 1
Week 36, USG, 1.024, n=34 1
Week 36, USG, 1.03, n=34 1
Week 36, USG, <=1.005, n=34 1
Week 36, UU, 1+, n=34 2
Week 36, UU, 0.1, n=34 3
Week 36, UU, 1, n=34 7
Week 36, UU, 2, n=34 1
Week 36, UU, 3, n=34 1
Week 36, UU, 4, n=34 1
Week 36, UU, Neg, n=34 1
Week 36, UU, trace, n=34 14
Week 36, UU, normal, n=34 4
Week 40, UB, (-), n=33 1
Week 40, UB, Neg, n=33 32
Week 40, UOB, 2+, n=33 1
Week 40, UOB, 3+, n=33 1
Week 40, UOB, (-), n=33 1
Week 40, UOB, Neg, n=33 30
Week 40, UG, (-), n=33 1
Week 40, UG, Neg, n=33 32
Week 40, UK, (-), n=33 1
Week 40, UK, Neg, n=33 31
Week 40, UK, trace, n=33 1
Week 40, pH, 5.5, n=33 4
Week 40, pH, 6, n=33 9
Week 40, pH, 6.5, n=33 6
Week 40, pH, 7, n=33 10
Week 40, pH, 7.5, n=33 4
Week 40, UP, (-), n=33 1
Week 40, UP, Neg, n=33 30
Week 40, UP, trace, n=33 2
Week 40, USG, 1.003, n=33 1
Week 40, USG, 1.004, n=33 1
Week 40, USG, 1.005, n=33 2
Week 40, USG, 1.006, n=33 1
Week 40, USG, 1.007, n=33 2
Week 40, USG, 1.01, n=33 2
Week 40, USG, 1.011, n=33 1
Week 40, USG, 1.012, n=33 3
Week 40, USG, 1.013, n=33 3
Week 40, USG, 1.014, n=33 1
Week 40, USG, 1.015, n=33 1
Week 40, USG, 1.016, n=33 3
Week 40, USG, 1.018, n=33 1
Week 40, USG, 1.019, n=33 2
Week 40, USG, 1.02, n=33 4
Week 40, USG, 1.022, n=33 1
Week 40, USG, 1.023, n=33 2
Week 40, USG, 1.024, n=33 1
Week 40, USG, 1.025, n=33 1
Week 40, UU, 1+, n=33 1
Week 40, UU, 0.1, n=33 3
Week 40, UU, 1, n=33 6
Week 40, UU, 2, n=33 1
Week 40, UU, 3, n=33 1
Week 40, UU, 4, n=33 1
Week 40, UU, Neg, n=33 1
Week 40, UU, trace, n=33 13
Week 40, UU, normal, n=33 6
Week 44, UB, (-), n=31 1
Week 44, UB, Neg, n=31 30
Week 44, UOB, 2+, n=31 2
Week 44, UOB, (-), n=31 1
Week 44, UOB, Neg, n=31 28
Week 44, UG, (-), n=31 1
Week 44, UG, 0.1, n=31 1
Week 44, UG, Neg, n=31 29
Week 44, UK, (-), n=31 1
Week 44, UK, Neg, n=31 29
Week 44, UK, trace, n=31 1
Week 44, pH, 5.5, n=31 3
Week 44, pH, 6, n=31 12
Week 44, pH, 6.5, n=31 8
Week 44, pH, 7, n=31 6
Week 44, pH, 7.5, n=31 2
Week 44, UP, (-), n=31 1
Week 44, UP, Neg, n=31 27
Week 44, UP, trace, n=31 3
Week 44, USG, 1.005, n=31 3
Week 44, USG, 1.007, n=31 2
Week 44, USG, 1.008, n=31 2
Week 44, USG, 1.01, n=31 3
Week 44, USG, 1.011, n=31 3
Week 44, USG, 1.012, n=31 1
Week 44, USG, 1.015, n=31 1
Week 44, USG, 1.016, n=31 1
Week 44, USG, 1.017, n=31 3
Week 44, USG, 1.018, n=31 1
Week 44, USG, 1.019, n=31 1
Week 44, USG, 1.02, n=31 2
Week 44, USG, 1.021, n=31 2
Week 44, USG, 1.022, n=31 1
Week 44, USG, 1.024, n=31 1
Week 44, USG, 1.025, n=31 2
Week 44, USG, 1.027, n=31 1
Week 44, USG, 1.03, n=31 1
Week 44, UU, 1+, n=31 3
Week 44, UU, 2+, n=31 1
Week 44, UU, 0.1, n=31 3
Week 44, UU, 1, n=31 7
Week 44, UU, 2, n=31 1
Week 44, UU, 4, n=31 1
Week 44, UU, Neg, n=31 1
Week 44, UU, trace, n=31 11
Week 44, UU, normal, n=31 3
Week 48, UB, (-), n=31 1
Week 48, UB, Neg, n=31 30
Week 48, UOB, 3+, n=31 1
Week 48, UOB, (-), n=31 1
Week 48, UOB, Neg, n=31 29
Week 48, UG, (-), n=31 1
Week 48, UG, Neg, n=31 30
Week 48, UK, (-), n=31 1
Week 48, UK, Neg, n=31 30
Week 48, pH, 5.5, n=31 4
Week 48, pH, 6, n=31 6
Week 48, pH, 6.5, n=31 14
Week 48, pH, 7, n=31 6
Week 48, pH, 8, n=31 1
Week 48, UP, (-), n=31 1
Week 48, UP, 10, n=31 1
Week 48, UP, Neg, n=31 26
Week 48, UP, trace, n=31 3
Week 48, USG, 1.005, n=31 1
Week 48, USG, 1.007, n=31 1
Week 48, USG, 1.009, n=31 2
Week 48, USG, 1.01, n=31 3
Week 48, USG, 1.011, n=31 2
Week 48, USG, 1.012, n=31 1
Week 48, USG, 1.013, n=31 1
Week 48, USG, 1.014, n=31 1
Week 48, USG, 1.015, n=31 4
Week 48, USG, 1.016, n=31 1
Week 48, USG, 1.017, n=31 1
Week 48, USG, 1.018, n=31 4
Week 48, USG, 1.019, n=31 3
Week 48, USG, 1.02, n=31 2
Week 48, USG, 1.025, n=31 2
Week 48, USG, 1.027, n=31 1
Week 48, USG, 1.03, n=31 1
Week 48, UU, 1+, n=31 2
Week 48, UU, 0.1, n=31 4
Week 48, UU, 1, n=31 3
Week 48, UU, 2, n=31 2
Week 48, UU, 3, n=31 1
Week 48, UU, Neg, n=31 1
Week 48, UU, trace, n=31 14
Week 48, UU, normal, n=31 4
Withdrawal, UB, 1+, n=10 1
Withdrawal, UB, (-), n=10 1
Withdrawal, UB, Neg, n=10 8
Withdrawal, UOB, 1+, n=10 1
Withdrawal, UOB, (-), n=10 2
Withdrawal, UOB, Neg, n=10 7
Withdrawal, UG, (-), n=10 2
Withdrawal, UG, Neg, n=10 8
Withdrawal, UK, (-), n=10 2
Withdrawal, UK, Neg, n=10 8
Withdrawal, pH, 5, n=10 1
Withdrawal, pH, 6, n=10 5
Withdrawal, pH, 6.5, n=10 2
Withdrawal, pH, 7, n=10 2
Withdrawal, UP, Neg, n=10 5
Withdrawal, UP, trace, n=10 5
Withdrawal, USG, 1.002, n=10 1
Withdrawal, USG, 1.009, n=10 1
Withdrawal, USG, 1.01, n=10 1
Withdrawal, USG, 1.017, n=10 1
Withdrawal, USG, 1.018, n=10 1
Withdrawal, USG, 1.019, n=10 2
Withdrawal, USG, 1.021, n=10 1
Withdrawal, USG, 1.023, n=10 1
Withdrawal, USG, 1.025, n=10 1
Withdrawal, UU, 1+, n=10 2
Withdrawal, UU, 1, n=10 1
Withdrawal, UU, Neg, n=10 1
Withdrawal, UU, trace, n=10 3
Withdrawal, UU, normal, n=10 3
52.Secondary Outcome
Title Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
Hide Description Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.
Time Frame FU Baseline and FU Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
SP2 Population.
Arm/Group Title Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
Hide Arm/Group Description:
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: Participants
FU Baseline, UB, (-) 3
FU Baseline, UB, Neg. 34
FU Baseline, UOB, 1+ 1
FU Baseline, UOB, 3+ 1
FU Baseline, UOB, (-) 3
FU Baseline, UOB, Neg. 32
FU Baseline, UG, (-) 3
FU Baseline, UG, Neg 34
FU Baseline, UK, (-) 3
FU Baseline, UK, Neg. 34
FU Baseline, pH, 5 1
FU Baseline, pH, 5.5 4
FU Baseline, pH, 6 10
FU Baseline, pH, 6.5 13
FU Baseline, pH, 7 8
FU Baseline, pH, 8 1
FU Baseline, UP, (-) 1
FU Baseline, UP, 10 1
FU Baseline, UP, Neg 27
FU Baseline, UP, trace 8
FU Baseline, USG, 1.002 1
FU Baseline, USG, 1.005 1
FU Baseline, USG, 1.007 1
FU Baseline, USG, 1.009 2
FU Baseline, USG, 1.01 2
FU Baseline, USG, 1.011 2
FU Baseline, USG, 1.012 1
FU Baseline, USG, 1.013 1
FU Baseline, USG, 1.014 1
FU Baseline, USG, 1.015 4
FU Baseline, USG, 1.016 1
FU Baseline, USG, 1.017 2
FU Baseline, USG, 1.018 4
FU Baseline, USG, 1.019 5
FU Baseline, USG, 1.02 2
FU Baseline, USG, 1.021 1
FU Baseline, USG, 1.024 1
FU Baseline, USG, 1.025 3
FU Baseline, USG, 1.027 1
FU Baseline, USG, 1.03 1
FU Baseline, UU, 1+ 4
FU Baseline, UU, 0.1 3
FU Baseline, UU, 1 3
FU Baseline, UU, 2 1
FU Baseline, UU, 3 1
FU Baseline, UU, Neg 2
FU Baseline, UU, trace 17
FU Baseline, UU, normal 6
FU Week 24, UB, (-) 2
FU Week 24, UB, Neg. 35
FU Week 24, UOB, 1+ 3
FU Week 24, UOB, 3+ 1
FU Week 24, UOB, (-) 2
FU Week 24, UOB, Neg. 26
FU Week 24, UOB, Trace 5
FU Week 24, UG, 1+ 1
FU Week 24, UG, (-) 2
FU Week 24, UG, 0.2 1
FUWeek 24, UG, Neg 33
FU Week 24, UK, (-) 2
FU Week 24, UK, Neg. 34
FU Week 24, UK, Trace. 1
FU Week 24, pH, 5 4
FU Week 24, pH, 5.5 9
FU Week 24, pH, 6 7
FU Week 24, pH, 6.5 10
FU Week 24, pH, 7 3
FU Week 24, pH, 7.5 4
FU Week 24, UP, (-) 2
FU Week 24, UP, Neg 32
FU Week 24, UP, Trace 3
FU Week 24, USG, 1.004 1
FU Week 24, USG, 1.005 2
FU Week 24, USG, 1.008 2
FU Week 24, USG, 1.01 5
FU Week 24, USG, 1.011 4
FU Week 24, USG, 1.012 1
FU Week 24, USG, 1.013 2
FU Week 24, USG, 1.015 3
FU Week 24, USG, 1.016 2
FU Week 24, USG, 1.017 4
FU Week 24, USG, 1.018 1
FU Week 24, USG, 1.019 1
FU Week 24, USG, 1.02 2
FU Week 24, USG, 1.021 2
FU Week 24, USG, 1.022 2
FU Week 24, USG, 1.023 1
FU Week 24, USG, 1.024 1
FU Week 24, USG, 1.025 1
FU Week 24, UU, 0.1 5
FU Week 24, UU, 1 2
FU Week 24, UU, 4 1
FU Week 24, UU, <1.0 1
FU Week 24, UU, Neg 2
FU Week 24, UU, Trace 18
FUWeek 24, UU, normal 8
53.Secondary Outcome
Title Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Hide Description The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
Time Frame Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
SP1 Population.
Arm/Group Title Eltrombopag Dose Escalation: Part 1
Hide Arm/Group Description:
Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Screening, normal, n=45 31
Screening, abnormal-NCS, n=45 14
Screening, abnormal-CS, n=45 0
Antiviral Baseline, normal, n=41 26
Antiviral Baseline, abnormal-NCS, n=41 14
Antiviral Baseline, abnormal-CS, n=41 1
Part 2, week 12, normal, n=36 29
Part 2, week 12, abnormal-NCS, n=36 7
Part 2, week 12, abnormal-CS, n=36 0
Part 2, week 24, normal, n=36 29
Part 2, week 24, abnormal-NCS, n=36 7