CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 759 enrolled
Drug / intervention
eltrombopag +1 moredrug
Likely dose
eltrombopag 100 mgfrom 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.

Search/NCT00529568
NCT00529568Phase 3Completed
CompareCT.gov

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)

GlaxoSmithKline·interventional·Posted Sep 14, 2007·Updated Nov 5, 2013

In Brief

A Phase 3 clinical trial evaluating eltrombopag and placebo for Hepatitis C, Chronic. Completed, enrolled 759 participants across 227 sites in 23 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Egypt, France, Germany, Greece, India, Israel, Italy, Pakistan, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartOct 1, 2007
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.8 years ago

Interventions

eltrombopagdrug

double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg

placebodrug

double-blind matched placebo control daily oral administration