A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of SB-497115-GR, a thrombopoietin receptor agonist, administered at 30, 50 and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenic purpura.

• Conditions: treatment of chronic immune thrombocytopenic purpura; MedDRA version: 6.1Level: PTClassification code 10021245

• Registration Number: EUCTR2004-000367-98-IT
• Lead Sponsor: GLAXO SMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified