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Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

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ClinicalTrials.gov Identifier: NCT00828750
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : December 1, 2011
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Idiopathic Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Idiopathic
Intervention Drug: Eltrombopag oral tablets
Enrollment 19

Recruitment Details  
Pre-assignment Details This study is an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of participants with idiopathic thrombocytopenic purpura (ITP) who had previously been enrolled in eltrombopag trial TRA108109 (NCT00540423).
Arm/Group Title Eltrombopag
Hide Arm/Group Description Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Period Title: Overall Study
Started 19
Completed 15
Not Completed 4
Reason Not Completed
Lack of Efficacy             3
Normal PC Remained While No Treatment             1
Arm/Group Title Eltrombopag
Hide Arm/Group Description Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
54.7  (13.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
12
  63.2%
Male
7
  36.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian – Japanese Heritage Number Analyzed 19 participants
19
1.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Hide Description An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Time Frame From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SP): all participants who received at least one dose of study medication
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
AE 19
SAE 6
Drug-Related AE 5
AE Leading to Withdrawal 0
SAE Leading to Withdrawal 0
Ongoing AE at the End of Study/Withdrawal 15
Mild AE 6
Moderate AE 13
Severe AE 0
2.Secondary Outcome
Title Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Hide Description Platelet counts were measured by blood draw.
Time Frame Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
Baseline, n=19 5.3
Week 1, n=19 21.1
Week 2, n=19 63.2
Week 3, n=19 78.9
Week 4, n=19 73.7
Week 8, n=19 73.7
Week 12, n=16 68.8
Week 16, n=17 76.5
Week 20, n=15 73.3
Week 24, n=17 82.4
Week 28, n=16 81.3
Week 32, n=16 68.8
Week 36, n=18 66.7
Week 40, n=17 47.1
Week 44, n=17 58.8
Week 48, n=18 83.3
Week 52, n=16 62.5
Week 56, n=14 57.1
Week 60, n=16 50.0
Week 64, n=14 57.1
Week 68, n=14 57.1
Week 72, n=12 50.0
Week 76, n=12 75.0
Week 80, n=12 66.7
Week 84, n=13 69.2
Week 88, n=12 75.0
Week 92, n=11 72.7
Week 96, n=11 54.5
Week 100, n=13 46.2
Week 104, n=11 45.5
Week 108, n=11 72.7
Week 112, n=7 57.1
Week 116, n=7 85.7
Week 120, n=5 40.0
Week 124, n=6 16.7
Week 128, n=4 25.0
Week 132, n=2 50.0
Week 136, n=1 100
Last Visit/Early Withdrawal Visit, n=19 57.9
3.Secondary Outcome
Title Median Platelet Counts
Hide Description Platelet counts were measured by blood draw.
Time Frame Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: Gi/L
Baseline, n=19
20.0
(3 to 117)
Week 1, n=19
36.0
(4 to 308)
Week 2, n=19
84.0
(14 to 463)
Week 3, n=19
85.0
(10 to 194)
Week 4, n=19
97.0
(5 to 259)
Week 8, n=19
102.0
(5 to 224)
Week 12, n=16
85.0
(23 to 238)
Week 16, n=17
76.0
(8 to 217)
Week 20, n=15
61.0
(7 to 252)
Week 24, n=17
70.0
(5 to 255)
Week 28, n=16
97.0
(17 to 202)
Week 32, n=16
75.0
(9 to 184)
Week 36, n=18
73.5
(3 to 233)
Week 40, n=17
45.0
(4 to 222)
Week 44, n=17
59.0
(3 to 226)
Week 48, n=18
71.5
(3 to 224)
Week 52, n=16
81.0
(5 to 303)
Week 56, n=14
58.0
(19 to 223)
Week 60, n=16
48.5
(4 to 252)
Week 64, n=14
57.5
(5 to 201)
Week 68, n=14
53.5
(3 to 200)
Week 72, n=12
51.5
(20 to 188)
Week 76, n=12
90.0
(39 to 241)
Week 80, n=12
67.5
(7 to 277)
Week 84, n=13
86.0
(20 to 280)
Week 88, n=12
65.0
(14 to 205)
Week 92, n=11
78.0
(22 to 194)
Week 96, n=11
57.0
(11 to 236)
Week 100, n=13
45.0
(15 to 282)
Week 104, n=11
44.0
(8 to 241)
Week 108, n=11
69.0
(2 to 318)
Week 112, n=7
56.0
(15 to 146)
Week 116, n=7
84.0
(38 to 148)
Week 120, n=5
21.0
(11 to 294)
Week 124, n=6
32.0
(8 to 156)
Week 128, n=4
37.0
(7 to 178)
Week 132, n=2
34.0
(18 to 50)
Week 136, n=1
51.0
(51 to 51)
Last Visit/Early Withdrawal Visit, n=19
75.0
(7 to 314)
4.Secondary Outcome
Title Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Hide Description Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Time Frame From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
Study Med. =<52 weeks (WKS), MCW=0 week (WK), n=2 0
Study Med. =<52 WKS, MCW >=1 WK, n=2 100
Study Med. =<52 WKS, MCW >=4 WKS, n=2 100
Study Med. =<52 WKS, MCW >=7 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=10 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=13 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=16 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=19 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=22 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=25 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=28 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=31 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=34 WKS, n=2 50.0
Study Med. =<52 WKS, MCW >=37 WKS, n=2 0
Study Med. =<52 WKS, MCW >=40 WKS, n=2 0
Study Med. =<52 WKS, MCW >=43 WKS, n=2 0
Study Med. >52 to =<78 WKS, MCW=0 WK, n=1 0
Study Med. >52 to =<78 WKS, MCW >=1 WK, n=1 100
Study Med. >52 to =<78 WKS, MCW >=4 WKS, n=1 100
Study Med. >52 to =<78 WKS, MCW >=7 WKS, n=1 100
Study Med. >52 to =<78 WKS, MCW >=10 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=13 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=16 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=19 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=22 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=25 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=28 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=31 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=34 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=37 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=40 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=43 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=52 WKS, n=1 0
Study Med. >52 to =<78 WKS, MCW >=65 WKS, n=1 0
Study Med. >78 to =<104 WKS, MCW=0 WK, n=1 0
Study Med. >78 to =<104 WKS, MCW >=1 WK, n=1 100
Study Med. >78 to =<104 WKS, MCW >=4 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=7 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=10 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=13 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=16 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=19 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=22 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=25 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=28 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=31 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=34 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=37 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=40 WKS, n=1 100
Study Med. >78 to =<104 WKS, MCW >=43 WKS, n=1 0
Study Med. >78 to =<104 WKS, MCW >=52 WKS, n=1 0
Study Med. >78 to =<104 WKS, MCW >=65 WKS, n=1 0
Study Med. >78 to =<104 WKS, MCW >=78 WKS, n=1 0
Study Med. >104 to =<130 WKS, MCW=0 WK, n=11 0
Study Med. >104 to =<130 WKS, MCW >=1 WK, n=11 100
Study Med. >104 to =<130 WKS, MCW >=4 WKS, n=11 90.9
Study Med. >104 to =<130 WKS, MCW >=7 WKS, n=11 90.9
Study Med. >104 to =<130 WKS, MCW >=10 WKS, n=11 90.9
Study Med. >104 to =<130 WKS, MCW >=13 WKS, n=11 90.9
Study Med. >104 to =<130 WKS, MCW >=16 WKS, n=11 81.8
Study Med. >104 to =<130 WKS, MCW >=19 WKS, n=11 63.6
Study Med. >104 to =<130 WKS, MCW >=22 WKS, n=11 54.5
Study Med. >104 to =<130 WKS, MCW >=25 WKS, n=11 45.5
Study Med. >104 to =<130 WKS, MCW >=28 WKS, n=11 45.5
Study Med. >104 to =<130 WKS, MCW >=31 WKS, n=11 36.4
Study Med. >104 to =<130 WKS, MCW >=34 WKS, n=11 36.4
Study Med. >104 to =<130 WKS, MCW >=37 WKS, n=11 18.2
Study Med. >104 to =<130 WKS, MCW >=40 WKS, n=11 18.2
Study Med. >104 to =<130 WKS, MCW >=43 WKS, n=11 18.2
Study Med. >104 to =<130 WKS, MCW >=52 WKS, n=11 18.2
Study Med. >104 to =<130 WKS, MCW >=65 WKS, n=11 9.1
Study Med. >104 to =<130 WKS, MCW >=78 WKS, n=11 9.1
Study Med. >104 to =<130 WKS, MCW >=91 WKS, n=11 9.1
Study Med. >104 to =<130 WKS, MCW >=104 WKS, n=11 0
Study Med. >104 to =<130 WKS, MCW >=117 WKS, n=6 0
Study Med. >130 WKS, MCW=0 WK, n=4 0
Study Med. >130 WKS, MCW >=1 WK, n=4 100
Study Med. >130 WKS, MCW >=4 WKS, n=4 50.0
Study Med. >130 WKS, MCW >=7 WKS, n=4 50.0
Study Med. >130 WKS, MCW >=10 WKS, n=4 50.0
Study Med. >130 WKS, MCW >=13 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=16 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=19 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=22 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=25 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=28 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=31 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=34 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=37 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=40 WKS, n=4 25.0
Study Med. >130 WKS, MCW >=43 WKS, n=4 0
Study Med. >130 WKS, MCW >=52 WKS, n=4 0
Study Med. >130 WKS, MCW >=65 WKS, n=4 0
Study Med. >130 WKS, MCW >=78 WKS, n=4 0
Study Med. >130 WKS, MCW >=91 WKS, n=4 0
Study Med. >130 WKS, MCW >=104 WKS, n=4 0
Study Med. >130 WKS, MCW >=117 WKS, n=4 0
Total, MCW=0 WK, n=19 0
Total, MCW >=1 WK, n=19 100
Total, MCW >=4 WKS, n=19 84.2
Total, MCW >=7 WKS, n=19 78.9
Total, MCW >=10 WKS, n=19 73.7
Total, MCW >=13 WKS, n=19 68.4
Total, MCW >=16 WKS, n=19 63.2
Total, MCW >=19 WKS, n=19 52.6
Total, MCW >=22 WKS, n=19 47.4
Total, MCW >=25 WKS, n=19 42.1
Total, MCW >=28 WKS, n=19 42.1
Total, MCW >=31 WKS, n=19 36.8
Total, MCW >=34 WKS, n=19 36.8
Total, MCW >=37 WKS, n=19 21.1
Total, MCW >=40 WKS, n=19 21.1
Total, MCW >=43 WKS, n=19 10.5
Total, MCW >=52 WKS, n=17 11.8
Total, MCW >=65 WKS, n=17 5.9
Total, MCW >=78 WKS, n=16 6.3
Total, MCW >=91 WKS, n=15 6.7
Total, MCW >=104 WKS, n=15 0
Total, MCW >=117 WKS, n=10 0
5.Secondary Outcome
Title Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
Hide Description Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Time Frame 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: weeks
Total, n=19
19.0
(1 to 91)
3 Months (13 Weeks), n=18
5.0
(0 to 11)
6 Months (26 Weeks), n=19
10.0
(0 to 24)
9 Months (39 Weeks), n=19
12.0
(0 to 36)
12 Months (52 Weeks), n=17
14.0
(0 to 36)
15 Months (65 Weeks), n=17
14.0
(0 to 40)
18 Months (78 Weeks), n=16
15.0
(0 to 53)
21 Months (91 Weeks), n=15
14.0
(0 to 64)
24 Months (104 Weeks), n=15
19.0
(0 to 76)
27 Months (117 Weeks), n=10
17.5
(0 to 91)
30 Months (130 Weeks), n=4
7.5
(3 to 40)
6.Secondary Outcome
Title Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Hide Description Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).
Time Frame Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
Baseline, n=19 63
Week 1, n=19 32
Week 2, n=19 21
Week 3, n=19 16
Week 4, n=19 5
Week 8, n=19 11
Week 12, n=16 13
Week 16, n=17 12
Week 20, n=15 40
Week 24, n=17 6
Week 28, n=16 25
Week 32, n=16 19
Week 36, n=18 39
Week 40, n=17 35
Week 44, n=17 24
Week 48, n=18 22
Week 52, n=16 31
Week 56, n=14 29
Week 60, n=16 13
Week 64, n=14 21
Week 68, n=14 29
Week 72, n=12 8
Week 76, n=12 8
Week 80, n=12 25
Week 84, n=13 0
Week 88, n=12 8
Week 92, n=11 9
Week 96, n=11 9
Week 100, n=13 8
Week 104, n=11 27
Week 108, n=11 27
Week 112, n=7 14
Week 116, n=7 0
Week 120, n=5 0
Week 124, n=6 33
Week 128, n=4 25
Week 132, n=2 50
Week 136, n=1 0
Last Visit/Early Withdrawal, n=19 21
7.Secondary Outcome
Title Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication
Hide Description Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.
Time Frame From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: percentage of participants
87
8.Secondary Outcome
Title Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Hide Description Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.
Time Frame From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
Any Rescue Therapy 21
New ITP Medication 11
Increase in Concomitant ITP Medication from B/L 11
Platelet Transfusion 0
Splenectomy 0
Time Frame Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eltrombopag
Hide Arm/Group Description Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
All-Cause Mortality
Eltrombopag
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eltrombopag
Affected / at Risk (%)
Total   6/19 (31.58%) 
Eye disorders   
Cataract  1  2/19 (10.53%) 
Gastrointestinal disorders   
Abdominal pain  1  1/19 (5.26%) 
Mallory-Weiss syndrome  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Lumbar spinal stenosis  1  1/19 (5.26%) 
Osteonecrosis  1  1/19 (5.26%) 
Spinal osteoarthritis  1  1/19 (5.26%) 
Renal and urinary disorders   
Cystitis-like symptom  1  1/19 (5.26%) 
Reproductive system and breast disorders   
Menorrhagia  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eltrombopag
Affected / at Risk (%)
Total   19/19 (100.00%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia  1  3/19 (15.79%) 
Anaemia  1  2/19 (10.53%) 
Idiopathic thrombocytopenic purpura  1  1/19 (5.26%) 
Ear and labyrinth disorders   
Presbyacusis  1  1/19 (5.26%) 
Eye disorders   
Cataract  1  2/19 (10.53%) 
Asthenopia  1  1/19 (5.26%) 
Chalazion  1  1/19 (5.26%) 
Conjunctival haemorrhage  1  1/19 (5.26%) 
Conjunctivitis  1  1/19 (5.26%) 
Conjunctivitis allergic  1  1/19 (5.26%) 
Eye pruritus  1  1/19 (5.26%) 
Vision blurred  1  1/19 (5.26%) 
Gastrointestinal disorders   
Diarrhoea  1  3/19 (15.79%) 
Abdominal pain lower  1  1/19 (5.26%) 
Dental caries  1  1/19 (5.26%) 
Food poisoning  1  1/19 (5.26%) 
Gastric ulcer  1  1/19 (5.26%) 
Gastritis  1  1/19 (5.26%) 
Gastritis atrophic  1  1/19 (5.26%) 
Gastritis erosive  1  1/19 (5.26%) 
Haemorrhoids  1  1/19 (5.26%) 
Reflux oesophagitis  1  1/19 (5.26%) 
Tongue discolouration  1  1/19 (5.26%) 
Toothache  1  1/19 (5.26%) 
Vomiting  1  1/19 (5.26%) 
General disorders   
Chest pain  1  2/19 (10.53%) 
Fatigue  1  2/19 (10.53%) 
Pyrexia  1  2/19 (10.53%) 
Chills  1  1/19 (5.26%) 
Oedema  1  1/19 (5.26%) 
Infections and infestations   
Nasopharyngitis  1  12/19 (63.16%) 
Bronchitis  1  3/19 (15.79%) 
Cystitis  1  2/19 (10.53%) 
Influenza  1  2/19 (10.53%) 
Cellulitis  1  1/19 (5.26%) 
Fungal infection  1  1/19 (5.26%) 
Parotitis  1  1/19 (5.26%) 
Pharyngitis  1  1/19 (5.26%) 
Rhinitis  1  1/19 (5.26%) 
Sinusitis  1  1/19 (5.26%) 
Tinea infection  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Compression fracture  1  2/19 (10.53%) 
Excoriation  1  1/19 (5.26%) 
Lip injury  1  1/19 (5.26%) 
Procedural pain  1  1/19 (5.26%) 
Upper limb fracture  1  1/19 (5.26%) 
Investigations   
Aspartate aminotransferase increased  1  2/19 (10.53%) 
Alanine aminotransferase increased  1  1/19 (5.26%) 
Glucose urine present  1  1/19 (5.26%) 
Haemoglobin decreased  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/19 (5.26%) 
Metabolic disorder  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  3/19 (15.79%) 
Tenosynovitis  1  2/19 (10.53%) 
Arthralgia  1  1/19 (5.26%) 
Intervertebral disc protrusion  1  1/19 (5.26%) 
Osteoarthritis  1  1/19 (5.26%) 
Periarthritis  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lip neoplasm  1  1/19 (5.26%) 
Nervous system disorders   
Headache  1  4/19 (21.05%) 
Hypoaesthesia  1  1/19 (5.26%) 
Psychiatric disorders   
Insomnia  1  3/19 (15.79%) 
Reproductive system and breast disorders   
Genital haemorrhage  1  1/19 (5.26%) 
Uterine prolapse  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  2/19 (10.53%) 
Rhinitis allergic  1  1/19 (5.26%) 
Upper respiratory tract inflammation  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Eczema  1  3/19 (15.79%) 
Dry skin  1  1/19 (5.26%) 
Heat rash  1  1/19 (5.26%) 
Papule  1  1/19 (5.26%) 
Pruritus  1  1/19 (5.26%) 
Seborrhoeic dermatitis  1  1/19 (5.26%) 
Urticaria  1  1/19 (5.26%) 
Vascular disorders   
Hypertension  1  3/19 (15.79%) 
Hot flush  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00828750     History of Changes
Other Study ID Numbers: 111433
First Submitted: January 22, 2009
First Posted: January 26, 2009
Results First Submitted: September 15, 2011
Results First Posted: December 1, 2011
Last Update Posted: September 17, 2018