At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 6,661 enrolled

Drug / intervention

peginterferon alfa-2a [Pegasys] +1 moredrug

Likely dose

peginterferon alfa-2a [Pegasys] 180microgramsfrom 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/NCT00922779

NCT00922779Phase 4Completed

Compare CT.gov

Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

Hoffmann-La Roche·interventional·Posted Jun 17, 2009·Updated Jan 20, 2016

In Brief

A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] and ribavirin for Hepatitis C, Chronic. Completed, enrolled 6,661 participants across 93 sites.

Detailed Summary

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. 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

CountriesRussia

Collaborators--

Timeline

Phase 4CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2002

First PostedJun 2009

Primary CompletionJun 2012

TodayJul 2026

First PostedJun 17, 2009

Enrollment StartJun 1, 2002

Primary CompletionJun 1, 2012

TodayJul 2, 2026

Enrollment to primary: 10 yearsPosted 17.0 years ago

Interventions

peginterferon alfa-2a [Pegasys]drug

180micrograms sc weekly for 12-48 weeks

ribavirindrug

800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)