MedTrace Logo

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

NCT00516321 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 687

Last updated 2013-11-05

Study results available
· View outcomes & findings →

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

DRUG

eltrombopag

25, 50, 75, 100 mg tablets taken once daily orally

DRUG

placebo

matched placebo taken once daily orally

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-04-30
Completion
2011-05-31

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00516321 on ClinicalTrials.gov