CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 102 enrolled
Drug / intervention
Peginterferon alfa-2b +1 morebiological
Likely dose
Peginterferon alfa-2b 1.0 µgfrom 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/NCT00687219
NCT00687219Phase 3Completed
CompareCT.gov

Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin

Merck Sharp & Dohme LLC·interventional·Posted May 30, 2008·Updated Apr 7, 2017

In Brief

A Phase 3 clinical trial evaluating Peginterferon alfa-2b and Ribavirin for Hepatitis C, Chronic and Liver Cirrhosis. Completed, enrolled 102 participants.

Detailed Summary

The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic, Liver Cirrhosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2008
Enrollment StartJun 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.1 years ago

Interventions

Peginterferon alfa-2bbiological

Administered at 1.0 µg/kg/week SC for 48 weeks

Ribavirindrug

Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL; treatment duration is 48 weeks