Trials / Completed
CompletedNCT00516321
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related 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-2a Plus Ribavirin
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 687 (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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | eltrombopag | 25, 50, 75, 100 mg tablets taken once daily orally |
| DRUG | placebo | matched placebo taken once daily orally |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2011-04-01
- Completion
- 2011-05-01
- First posted
- 2007-08-15
- Last updated
- 2013-11-05
- Results posted
- 2012-07-30
Locations
191 sites across 25 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, Pakistan, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00516321. Inclusion in this directory is not an endorsement.