CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 130 enrolled
Drug / intervention
Pegylated interferon alfa-2b +1 morebiological
Likely dose
Ribavirin 10.6 mg/kgfrom 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/NCT00686517
NCT00686517Phase 3Completed
CompareCT.gov

An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C

Merck Sharp & Dohme LLC·interventional·Posted May 30, 2008·Updated Apr 5, 2017

In Brief

A Phase 3 clinical trial evaluating Pegylated interferon alfa-2b and Ribavirin for Hepatitis C. Completed, enrolled 130 participants.

Detailed Summary

The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
CollaboratorsBioikos Ambiente Srl

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2008
Enrollment StartDec 1, 2003
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 18.1 years ago

Interventions

Pegylated interferon alfa-2bbiological

1.5 ug/kg/week SC for 12 or 24 weeks

Ribavirindrug

Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks