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Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures (ELEVATE)

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ClinicalTrials.gov Identifier: NCT00678587
Recruitment Status : Terminated (GSK decision)
First Posted : May 15, 2008
Results First Posted : November 8, 2010
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Non-alcoholic Steatohepatitis
Chronic Liver Disease
HCV
NASH - Nonalcoholic Steatohepatitis
HIV Infection
Thrombocytopenia
Hepatitis C Virus
HBV
Human Immunodeficiency Virus
Liver Diseases
Hepatitis B Virus
Interventions Drug: Eltrombopag
Drug: Placebo
Enrollment 292
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description Matching placebo Eltrombopag 75 mg administered orally once daily
Period Title: Overall Study
Started 147 145
Completed 127 127
Not Completed 20 18
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             1             0
Protocol Violation             2             1
Study Closed/Terminated             1             0
Lost to Follow-up             3             5
Investigator Discretion             2             6
Withdrew Consent             8             3
Arm/Group Title Placebo Eltrombopag 75 mg Total
Hide Arm/Group Description Matching placebo Eltrombopag 75 mg administered orally once daily Total of all reporting groups
Overall Number of Baseline Participants 147 145 292
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 145 participants 292 participants
53.5  (11.78) 51.6  (11.04) 52.5  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 145 participants 292 participants
Female
55
  37.4%
49
  33.8%
104
  35.6%
Male
92
  62.6%
96
  66.2%
188
  64.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 147 participants 145 participants 292 participants
White 93 85 178
Central/South Asian Heritage 33 41 74
Japanese/East Asian/South East Asian Heritage 19 14 33
African American/African Heritage 2 4 6
Native Hawaiian/Other Pacific Islander and White 0 1 1
Number of participants categorized into the indicated Child-Pugh (CP) Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 147 participants 145 participants 292 participants
Child-Pugh Class A 59 68 127
Child-Pugh Class B 64 57 121
Child-Pugh Class C 17 10 27
[1]
Measure Description: The CP score (ranging from 5 to 15; 5=mild, 15=severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess liver disease severity. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study. The number of participants analyzed is 140 for placebo and 135 for Eltrombopag; not all participants were compliant and had their baseline CP score measured.
Model for End-Stage Liver Disease (MELD) Score at Baseline   [1] 
Median (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 147 participants 145 participants 292 participants
12
(6 to 25)
12
(6 to 24)
12
(6 to 25)
[1]
Measure Description: MELD uses the following formula to calculate a participant’s likelihood of dying within 3 months from liver disease: 3.8 x log (e) (bilirubin milligrams [mg]/deciliter [dL]) + 11.2 x log (e) (international ratio for prothrombin time) + 9.6 log (e) (creatinine mg/dL). Scores range from 6 (least ill) to 40 (most ill): 40 or more, 71.3% mortality; 30-39, 52.6% mortality; 20-29, 19.6% mortality; 10-19, 6.0% mortality; <9, 1.9% mortality. The number of participants analyzed is 140 for placebo and 135 for Eltrombopag; not all participants were compliant and had their baseline MELD score measured.
1.Primary Outcome
Title Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures
Hide Description A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.
Time Frame Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who were randomized to treatment
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 147 145
Measure Type: Number
Unit of Measure: participants
28 104
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Eltrombopag 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute difference in proportions
Estimated Value 52.8
Confidence Interval (2-Sided) 95%
43.2 to 62.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures
Hide Description The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).
Time Frame Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 147 145
Measure Type: Number
Unit of Measure: participants
34 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Eltrombopag 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-15.1 to 3.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With the Indicated Number of Platelet Transfusions Administered
Hide Description Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study.
Time Frame Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 147 145
Measure Type: Number
Unit of Measure: participants
0 30 106
1 93 24
2 3 1
3 2 0
4 3 0
5 0 0
6 1 0
Died/withdrew prior to any platelet transfusions 15 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Eltrombopag 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline
Hide Description Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).
Time Frame Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 147 145
Median (Full Range)
Unit of Measure: Gi/L
Screening, n=147, 145
40.0
(8 to 70)
40.0
(3 to 55)
Day 1, n=145, 141
40.0
(8 to 222)
40.0
(12 to 62)
Day 8, n=139, 134
41.0
(6 to 190)
58.5
(20 to 337)
Day 15, n=132, 131
39.0
(6 to 200)
103.0
(25 to 397)
Days 16-19, n=50, 49
41.5
(18 to 250)
107.0
(30 to 406)
Procedure + 7 day follow-up, n=128, 125
44.0
(17 to 150)
148
(30 to 493)
Procedure + 14 day follow-up, n=116, 125
47.5
(13 to 370)
110
(18 to 805)
Procedure + 21 day follow-up, n=120, 117
44.5
(11 to 200)
62.0
(15 to 967)
Procedure + 30 day follow-up, n=125, 127
40.0
(10 to 200)
50.0
(14 to 999)
Early withdrawal, n=9, 8
40.0
(11 to 195)
41.0
(32 to 140)
Maximum post-baseline, n=144, 140
53.0
(16 to 370)
152
(32 to 999)
5.Secondary Outcome
Title Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline
Hide Description Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).
Time Frame Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 147 145
Measure Type: Number
Unit of Measure: participants
Screening, <50 Gi/L, n=147, 145 133 136
Screening, >=50-<=80 Gi/L, n=147, 145 14 8
Screening, >80-<=200 Gi/L, n=147, 145 0 0
Screening, >200-<=400 Gi/L, n=147, 145 0 0
Screening, >400 Gi/L, n=147, 145 0 0
Day 8, <50 Gi/L, n=139, 135 98 48
Day 8, >=50-<=80 Gi/L, n=139, 135 34 50
Day 8, >80-<=200 Gi/L, n=139, 135 7 33
Day 8, >200-<=400 Gi/L, n=139, 135 0 3
Day 8, >400 Gi/L, n=139, 135 0 0
Day 15, <50 Gi/L, n=132, 131 98 14
Day 15, >=50-<=80 Gi/L, n=132, 131 26 31
Day 15, >80-<=200 Gi/L, n=132, 131 8 67
Day 15, >200-<=400 Gi/L, n=132, 131 0 19
Day 15, >400 Gi/L, n=132, 131 0 0
Procedure + 7 Day FU, <50 Gi/L, n=128, 126 78 11
Procedure + 7 Day FU, >=50-<=80 Gi/L, n=128, 126 38 20
Procedure + 7 Day FU, >80-<=200 Gi/L, n=128, 126 12 60
Procedure + 7 Day FU, >200-<=400 Gi/L, n=128, 126 0 30
Procedure + 7 Day FU, >400 Gi/L, n=128, 126 0 4
Procedure + 14 Day FU, <50 Gi/L, n=117, 125 63 22
Procedure + 14 Day FU, >=50-<=80 Gi/L, n=117, 125 40 21
Procedure + 14 Day FU, >80-<=200 Gi/L, n=117, 125 11 62
Procedure + 14 Day FU, >200-<=400 Gi/L, n=117, 125 2 17
Procedure + 14 Day FU, >400 Gi/L, n=117, 125 0 3
Procedure + 21 Day FU, <50 Gi/L, n=121, 117 80 38
Procedure + 21 Day FU, >=50-<=80 Gi/L, n=121, 117 30 33
Procedure + 21 Day FU, >80-<=200 Gi/L, n=121, 117 10 38
Procedure + 21 Day FU, >200-<=400 Gi/L, n=121, 117 0 7
Procedure + 21 Day FU, >400 Gi/L, n=121, 117 0 1
Maximum Post-Baseline, <50 Gi/L, n=144, 140 60 11
Maximum Post-Baseline, >=50-<=80 Gi/L, n=144, 140 53 23
Maximum Post-Baseline, >80-<=200 Gi/L, n=144, 140 28 62
Maximum Post-Baseline, >200-<=400 Gi/L, n=144, 140 3 37
Maximum Post-Baseline, >400 Gi/L, n=144, 140 0 7
6.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category
Hide Description An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations.
Time Frame Screening to Procedure +30 day follow-up or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomized participants who received at least one dose of study medication
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 145 142
Measure Type: Number
Unit of Measure: participants
AEs during study 85 79
Drug-related AEs in >1 participant 15 31
Throboembolic AEs 2 6
Bleeding AEs 25 19
Hepatobiliary AEs 16 24
Malignancy AEs 1 1
Renal AEs 4 2
Death on study 2 3
SAEs in >1 participant during study 17 19
Drug-related SAEs in >1 participant 4 9
Thrombocytopenia 1 1
Progression of pre-existing cataract n=145,143 2 0
Incident cataract develpment n=145,143 2 4
Decrease in visual acuity n=121,124 19 21
Renal function abnormality n=145,143 27 28
Clinically significant change in ECG n=128,130 0 1
7.Secondary Outcome
Title Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant
Hide Description [Not Specified]
Time Frame Screening to Procedure +30 day follow-up or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 145 143
Measure Type: Number
Unit of Measure: participants
4 9
8.Secondary Outcome
Title Number of Participants With the Indicated Event Relating to Vision
Hide Description The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart).
Time Frame Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study medication. Data are missing for some participants.
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 145 143
Measure Type: Number
Unit of Measure: participants
Progression of pre-existing cataract, n=145, 143 2 0
Cataract development, n=145, 143 2 4
Decrease in visual acuity, n=121, 124 19 21
9.Secondary Outcome
Title Number of Participants With Renal Function Abnormality
Hide Description Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test.
Time Frame Screening to Procedure +30 day follow-up or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 145 143
Measure Type: Number
Unit of Measure: participants
27 28
10.Secondary Outcome
Title Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results
Hide Description A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site.
Time Frame Screening, Baseline, Day 15, and Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data were missing for some participants.
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 128 130
Measure Type: Number
Unit of Measure: participants
0 1
11.Secondary Outcome
Title Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)
Hide Description AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Subpopulation: all participants who were treated with eltrombopag and provided evaluable PK samples
Arm/Group Title Eltrombopag 75 mg
Hide Arm/Group Description:
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: hour*micrograms (ug)/milliliter (mL)
250
(211 to 296)
12.Secondary Outcome
Title Pharmacokinetics (PK) of Eltrombopag, Cmax
Hide Description Cmax is the steady state peak plasma concentration of a drug observed after its administration.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Subpopulation
Arm/Group Title Eltrombopag 75 mg
Hide Arm/Group Description:
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/mL
11.6
(9.8 to 13.6)
13.Secondary Outcome
Title Pharmacokinetics (PK) of Eltrombopag, t1/2
Hide Description t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Subpopulation
Arm/Group Title Eltrombopag 75 mg
Hide Arm/Group Description:
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours
70.3
(60.7 to 81.5)
14.Secondary Outcome
Title Pharmacokinetics (PK) of Eltrombopag, CL/F
Hide Description CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Subpopulation
Arm/Group Title Eltrombopag 75 mg
Hide Arm/Group Description:
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters/hour
0.30
(0.25 to 0.36)
15.Secondary Outcome
Title Mean Number of Days Spent in the Hospital
Hide Description The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study.
Time Frame Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data are missing for some participants.
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: days
1.3  (3.77) 1.7  (6.43)
16.Secondary Outcome
Title Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures
Hide Description The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study.
Time Frame Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data are missing for some participants.
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description:
Matching placebo
Eltrombopag 75 mg administered orally once daily
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: unscheduled events
Unscheduled office visits 0.8  (1.64) 1.0  (2.91)
Unscheduled laboratory tests 1.1  (3.78) 1.8  (5.67)
Unscheduled procedures 0.3  (0.81) 0.4  (1.65)
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 the end of Week 7).
Adverse Event Reporting Description The Safety Population, comprised of all randomized participants who received at least one dose of study medication, was used for the collection of AEs and SAEs.
 
Arm/Group Title Placebo Eltrombopag 75 mg
Hide Arm/Group Description Matching placebo Eltrombopag 75 mg administered orally once daily
All-Cause Mortality
Placebo Eltrombopag 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Eltrombopag 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   17/145 (11.72%)   19/143 (13.29%) 
Blood and lymphatic system disorders     
Thrombocytosis  1  0/145 (0.00%)  1/143 (0.70%) 
Thrombocytopenia  1  1/145 (0.69%)  0/143 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/145 (0.00%)  1/143 (0.70%) 
Acute myocardial infaction  1  1/145 (0.69%)  0/143 (0.00%) 
Eye disorders     
Cataract  1  3/145 (2.07%)  1/143 (0.70%) 
Macular degeneration  1  0/145 (0.00%)  1/143 (0.70%) 
Visual accuity reduced  1  0/145 (0.00%)  1/143 (0.70%) 
Gastrointestinal disorders     
Mesenteric vein thrombosis  1  1/145 (0.69%)  3/143 (2.10%) 
Abdominal pain  1  0/145 (0.00%)  1/143 (0.70%) 
Appendix disorder  1  0/145 (0.00%)  1/143 (0.70%) 
Ascites  1  0/145 (0.00%)  1/143 (0.70%) 
Ileus paralytic  1  0/145 (0.00%)  1/143 (0.70%) 
Colitis ischaemia  1  0/145 (0.00%)  1/143 (0.70%) 
Intestinal perforation  1  0/145 (0.00%)  1/143 (0.70%) 
Oesophageal haemorrhage  1  0/145 (0.00%)  1/143 (0.70%) 
Pancreatitis acute  1  0/145 (0.00%)  1/143 (0.70%) 
Peritonitis  1  0/145 (0.00%)  1/143 (0.70%) 
Upper gastrointestinal haemorrhage  1  0/145 (0.00%)  1/143 (0.70%) 
Gastric ulcer haemorrhage  1  1/145 (0.69%)  0/143 (0.00%) 
Impaired gastric emptying  1  1/145 (0.69%)  0/143 (0.00%) 
Nausea  1  1/145 (0.69%)  0/143 (0.00%) 
Oesophageal varices haemorrhage  1  1/145 (0.69%)  0/143 (0.00%) 
Rectal haemorrhage  1  2/145 (1.38%)  0/143 (0.00%) 
General disorders     
Pyrexia  1  0/145 (0.00%)  1/143 (0.70%) 
Multi-organ failure  1  1/145 (0.69%)  0/143 (0.00%) 
Hepatobiliary disorders     
Portal vein thrombosis  1  2/145 (1.38%)  4/143 (2.80%) 
Chronic hepatic failure  1  0/145 (0.00%)  1/143 (0.70%) 
Hepatorenal syndrome  1  1/145 (0.69%)  0/143 (0.00%) 
Infections and infestations     
Sepsis  1  0/145 (0.00%)  2/143 (1.40%) 
Appendicitis  1  0/145 (0.00%)  1/143 (0.70%) 
Pneumonia  1  0/145 (0.00%)  1/143 (0.70%) 
Gastroenteristis  1  1/145 (0.69%)  1/143 (0.70%) 
Pyelonephritis acute  1  0/145 (0.00%)  1/143 (0.70%) 
Peritonitis acute  1  1/145 (0.69%)  0/143 (0.00%) 
Tuberculosis  1  1/145 (0.69%)  0/143 (0.00%) 
Injury, poisoning and procedural complications     
Wound dehiscence  1  1/145 (0.69%)  0/143 (0.00%) 
Metabolism and nutrition disorders     
Fluid retention  1  0/145 (0.00%)  1/143 (0.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma  1  0/145 (0.00%)  1/143 (0.70%) 
Nervous system disorders     
Hepatic encephalopathy  1  3/145 (2.07%)  2/143 (1.40%) 
Encephalopathy  1  1/145 (0.69%)  1/143 (0.70%) 
Renal and urinary disorders     
Renal failure acute  1  1/145 (0.69%)  0/143 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/145 (0.00%)  1/143 (0.70%) 
Hepatic hydrothorax  1  0/145 (0.00%)  1/143 (0.70%) 
Pneumonia aspiration  1  0/145 (0.00%)  1/143 (0.70%) 
Pneumothorax  1  1/145 (0.69%)  0/143 (0.00%) 
Vascular disorders     
Orthostatic hypotension  1  1/145 (0.69%)  0/143 (0.00%) 
Shock  1  1/145 (0.69%)  0/143 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, v12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Eltrombopag 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   35/145 (24.14%)   40/143 (27.97%) 
Gastrointestinal disorders     
Abdominal pain  1  7/145 (4.83%)  7/143 (4.90%) 
Nausea  1  7/145 (4.83%)  7/143 (4.90%) 
Diarrhoea  1  5/145 (3.45%)  7/143 (4.90%) 
General disorders     
Pyrexia  1  10/145 (6.90%)  8/143 (5.59%) 
Nervous system disorders     
Headache  1  6/145 (4.14%)  11/143 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, v12.1
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: NCT00678587     History of Changes
Other Study ID Numbers: TPL104054
First Submitted: May 13, 2008
First Posted: May 15, 2008
Results First Submitted: October 10, 2010
Results First Posted: November 8, 2010
Last Update Posted: October 12, 2018