At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 23 enrolled
Drug / intervention
SB-497115-GR 12.5mg +3 moredrug
Likely dose
SB-497115-GR 12.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- <Phase II/III Study>
In Brief
A Phase 3 clinical trial evaluating SB-497115-GR 12.5mg, SB-497115-GR 25mg, and 2 other interventions for Chronic Idiopathic Thrombocytopenic Purpura and Purpura, Thrombocytopenic, Idiopathic. Completed, enrolled 23 participants across 7 sites.
Detailed Summary
This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedOct 2007
Primary CompletionDec 2008
TodayJul 2026
First PostedOct 8, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.7 years ago
Interventions
SB-497115-GR 12.5mgdrug
SB-497115-GR 12.5mg tablet once a day
SB-497115-GR 25mgdrug
SB-497115-GR 25mg tablet once a day
SB-497115-GR 12.5mg matching placebodrug
SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day
SB-497115-GR 50 mgdrug
SB-497115-GR 25mg tablet x2 once a day