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Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00861601
First received: March 5, 2009
Last updated: October 7, 2010
Last verified: October 2010
History of Changes
Results First Received: May 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Thrombocytopenia
Liver Diseases
Interventions: Drug: eltrombopag 12.5 milligrams (mg) tablet
Drug: eltrombopag 25 mg tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Eltrombopag 12.5 mg Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
Eltrombopag 25 mg Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Eltrombopag 37.5 mg Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.

Participant Flow:   Overall Study
    Eltrombopag 12.5 mg     Eltrombopag 25 mg     Eltrombopag 37.5 mg  
STARTED     12     14     12  
COMPLETED     12     14     12  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Eltrombopag 12.5 mg Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
Eltrombopag 25 mg Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Eltrombopag 37.5 mg Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Total Total of all reporting groups

Baseline Measures
    Eltrombopag 12.5 mg     Eltrombopag 25 mg     Eltrombopag 37.5 mg     Total  
Number of Participants  
[units: participants]
 		  12     14     12     38  
Age  
[units: years]
Mean ± Standard Deviation 		  62.2  ± 10.51     57.7  ± 8.69     66.3  ± 8.84     61.8  ± 9.78  
Gender  
[units: participants]
 		       
Female     4     4     4     12  
Male     8     10     8     26  
Race/Ethnicity, Customized  
[units: participants]
 		  12     14     12     38  
Number of participants categorized into the indicated Child-Pugh (CP) Class [1]
[units: participants]
 		       
Class A     8     8     7     23  
Class B     4     6     5     15  
Class C     0     0     0     0  
[1] The CP score (ranging from 5 to 15, with 5 being mild and 15 being severe), 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 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



  Outcome Measures
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1.  Primary:   Change From Baseline in Platelet Counts on Day 15   [ Time Frame: Baseline, Day 15 ]
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2.  Secondary:   Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)   [ Time Frame: Baseline, Day 15 ]
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3.  Secondary:   Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)   [ Time Frame: Baseline, Day 15 ]
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4.  Secondary:   Percent Change From Baseline in Platelet Counts on Day 15   [ Time Frame: Baseline, Day 15 ]
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5.  Secondary:   Platelet Counts by Treatment Visit   [ Time Frame: Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22) ]
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6.  Secondary:   Platelet Counts by Post-Treatment Visit   [ Time Frame: 4 days post-treatment, 8 days post-treatment, and 15 days post-treatment ]
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7.  Secondary:   Platelet Counts at Day 22   [ Time Frame: Day 22 ]
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8.  Secondary:   Change From Baseline in Platelet Counts by Treatment Visit   [ Time Frame: Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22) ]
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9.  Secondary:   Change From Baseline in Platelet Counts by Post-Treatment Visit   [ Time Frame: 4 days post-treatment, 8 days post-treatment, and 15 days post-treatment ]
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10.  Secondary:   Percentage of Responders on Day 15   [ Time Frame: Day 15 ]
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11.  Secondary:   Percentage of Responders on Day 22   [ Time Frame: Day 22 ]
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12.  Secondary:   Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class   [ Time Frame: Baseline, Day 15 ]
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13.  Secondary:   Change From Baseline in Platelet Counts on Day 15 by Sex   [ Time Frame: Baseline, Day 15 ]
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14.  Secondary:   Change From Baseline in Platelet Counts on Day 15 by Age   [ Time Frame: Baseline, Day 15 ]
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15.  Secondary:   Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg   [ Time Frame: Day 14, Day 15 ]
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16.  Secondary:   Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg   [ Time Frame: Day 14, Day 15 ]
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17.  Secondary:   Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg   [ Time Frame: Day 14, Day 15 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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