CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,469 enrolled
Drug / intervention
Copegus +3 moredrug
Likely dose
Peginterferon alfa-2a (Pegasys) 180 micrograms subcutaneously weekly + Ribavirin (Copegus) 400 mg orally twice daily for 16 or 24 weeksAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Chronic hepatitis C genotype 2 or 3 infection
  • ✓Liver biopsy within 24 months confirming chronic hepatitis C
  • ✓Willingness to use 2 forms of contraception during study and 6 months after study
Key exclusion· 5
  • ✕Pregnancy or breastfeeding
  • ✕Decompensated liver disease
  • ✕Other forms of liver disease or liver cancer
  • ✕HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00077636
NCT00077636Phase 4Completed
CompareCT.gov

A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

Hoffmann-La Roche·interventional·Posted Feb 13, 2004·Updated Feb 23, 2016

In Brief

A Phase 4 clinical trial evaluating Copegus and peginterferon alfa-2a [Pegasys] for Hepatitis C, Chronic. Completed, enrolled 1,469 participants across 132 sites in 9 countries.

Detailed Summary

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustralia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, Spain, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2004
Enrollment StartDec 1, 2003
Primary CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 22.4 years ago

Interventions

Copegusdrug

400mg po bid for 16 weeks

Copegusdrug

400mg po bid for 24 weeks

peginterferon alfa-2a [Pegasys]drug

180 micrograms sc weekly for 16 weeks

peginterferon alfa-2a [Pegasys]drug

180 micrograms sc weekly for 24 weeks