CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 948 enrolled
Drug / intervention
Ribavirin +5 moredrug
Likely dose
Peginterferon alfa-2a 360 micrograms SC weekly for 12 weeks, then 180 micrograms SC weekly for 60 weeks; plus ribavirin 1000/1200 mg orally daily for 72 weeksAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Confirmed chronic hepatitis C infection
  • ✓Liver biopsy within 24 months confirming CHC
  • ✓Prior treatment failure: lack of response to ≥12 weeks of peginterferon alfa-2b/ribavirin combination therapy
Key exclusion· 5
  • ✕Pregnancy or breastfeeding
  • ✕Male partners of pregnant women
  • ✕Decompensated liver disease
  • ✕Other liver diseases including hepatocellular carcinoma

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

Search/NCT00087646
NCT00087646Phase 4Completed
CompareCT.gov

A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

Hoffmann-La Roche·interventional·Posted Jul 14, 2004·Updated Jan 14, 2016

In Brief

A Phase 4 clinical trial evaluating Ribavirin and peginterferon alfa-2a [Pegasys] for Hepatitis C, Chronic. Completed, enrolled 948 participants across 104 sites in 14 countries.

Detailed Summary

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBelgium, Brazil, Canada, France, Germany, Greece, Italy, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2004
Enrollment StartSep 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 22.0 years ago

Interventions

Ribavirindrug

1000/1200mg po daily for 72 weeks

Ribavirindrug

1000/1200mg po daily for 48 weeks

peginterferon alfa-2a [Pegasys]drug

360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks

peginterferon alfa-2a [Pegasys]drug

360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.

peginterferon alfa-2a [Pegasys]drug

180 micrograms sc weekly for 72 weeks

peginterferon alfa-2a [Pegasys]drug

180 micrograms sc weekly for 48 weeks