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

NCT00529568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 759

Last updated 2013-11-05

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-08-31
Completion
2011-08-31

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

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 NCT00529568 on ClinicalTrials.gov