CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 696 enrolled
Drug / intervention
peginterferon alfa-2b (SCH 54031) +4 morebiological
Likely dose
peginterferon alfa-2b (SCH 54031) 1.5 mcg/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/NCT00302081
NCT00302081Phase 3Completed
CompareCT.gov

Comparison of Three Regimens of PEG-Intron and Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients

Merck Sharp & Dohme LLC·interventional·Posted Mar 13, 2006·Updated Apr 5, 2017

In Brief

A Phase 3 clinical trial evaluating peginterferon alfa-2b (SCH 54031) and ribavirin (SCH 18908) for Hepatitis C, Chronic. Completed, enrolled 696 participants.

Detailed Summary

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
Countries--
CollaboratorsIntegrated Therapeutics Group

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2006
Enrollment StartAug 1, 2003
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.3 years ago

Interventions

peginterferon alfa-2b (SCH 54031)biological

1.5 mcg/kg QW SC for 24 weeks

peginterferon alfa-2b (SCH 54031)biological

1.0 mcg/kg QW SC for 24 weeks

peginterferon alfa-2b (SCH 54031)biological

1.5 mcg/kg QW SC for 16 weeks

ribavirin (SCH 18908)drug

800-1200 mg daily for 24 weeks

ribavirin (SCH 18908)drug

800-1200 mg daily for 16 weeks