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eltrombopag 12.5 milligrams

Phase 2

Liver Diseases | Small molecule | Gastrointestinal |GSK plc|Last Updated: May 12, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00861601Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver DiseasePHASE2 COMPLETED 38 — — Jan 1, 2009Aug 1, 2009May 12, 201510 Japan
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Study Endpoints
Primary Endpoints
Change From Baseline in Platelet Counts on Day 15
Baseline, Day 15

Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.

Secondary Endpoints
Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)
Baseline, Day 15
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)
Baseline, Day 15
Percent Change From Baseline in Platelet Counts on Day 15
Baseline, Day 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
low doseEXPERIMENTALeltrombopag 12.5 mg/day
middle doseEXPERIMENTALeltrombopag 25 mg/day
high doseEXPERIMENTALeltrombopag 37.5 mg/day
Interventions
NameTypeDescription
eltrombopag 12.5 milligrams (mg) tabletDRUGeltrombopag 12.5 mg tablet once a day
eltrombopag 25 mg tabletDRUGeltrombopag 25 mg tablet once a day
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Subject who agree to comply with protocol requirements and instructions and who provide signed and dated written informed consent. * Male and female subjects, ≥20 years of age (at the time of informed consent) with chronic liver disease. * Child-Pugh score \<=9. * A baseline p...

Countries:Japan
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