NCT00529568

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 759 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	eltrombopag	double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg
DRUG	placebo	double-blind matched placebo control daily oral administration

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2007-09-14
• Last updated: 2013-11-05
• Results posted: 2012-05-17

Locations

227 sites across 23 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Egypt, France, Germany, Greece, India, Israel, Italy, Pakistan, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Ukraine