CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 395 enrolled
Drug / intervention
peginterferon alfa-2a [Pegasys] +3 moredrug
Likely dose
peginterferon alfa-2a [Pegasys] 180 mcgfrom 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/NCT01258101
NCT01258101Phase 4Completed
CompareCT.gov

Randomized, Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3

Hoffmann-La Roche·interventional·Posted Dec 10, 2010·Updated Jul 11, 2016

In Brief

A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] and ribavirin for Hepatitis C, Chronic. Completed, enrolled 395 participants across 18 sites.

Detailed Summary

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustria
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2010
Enrollment StartMay 1, 2003
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 15.6 years ago

Interventions

peginterferon alfa-2a [Pegasys]drug

180 mcg sc weekly, 24 weeks

peginterferon alfa-2a [Pegasys]drug

180 mcg sc weekly, 16 weeks

ribavirindrug

800 mg orally daily

ribavirindrug

400 mg orally daily