NCT00540423

Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

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>

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Idiopathic Thrombocytopenic Purpura
• Purpura, Thrombocytopenic, Idiopathic

Interventions

Type	Name	Description
DRUG	SB-497115-GR 12.5mg	SB-497115-GR 12.5mg tablet once a day
DRUG	SB-497115-GR 25mg	SB-497115-GR 25mg tablet once a day
DRUG	SB-497115-GR 12.5mg matching placebo	SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day
DRUG	SB-497115-GR 50 mg	SB-497115-GR 25mg tablet x2 once a day

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-10-08
• Last updated: 2011-03-30
• Results posted: 2009-12-31

Locations

7 sites across 1 country: Japan