CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 631 enrolled
Drug / intervention
peginterferon alfa-2b (SCH 54031)biological
Likely dose
Peginterferon alfa-2b 0.5 µg/kg subcutaneously once weeklyAI-extracted
Key inclusion· 3
  • ✓Age 18-65 years at entry
  • ✓Non-responder to prior treatment with alpha interferon plus ribavirin for minimum 3 months
  • ✓Liver biopsy demonstrating cirrhosis (METAVIR F4)
Key exclusion· 4
  • ✕Any cause of liver disease other than chronic hepatitis C
  • ✕History or presence of complications of cirrhosis
  • ✕Alcohol or illicit drug abuse, or methadone treatment within past 2 years
  • ✕Diseases or conditions that could interfere with study participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00048724
NCT00048724Phase 3Completed
CompareCT.gov

PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin

Merck Sharp & Dohme LLC·interventional·Posted Nov 8, 2002·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating peginterferon alfa-2b (SCH 54031) for Chronic Hepatitis C and Cirrhosis. Completed, enrolled 631 participants.

Detailed Summary

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Cirrhosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2002
Enrollment StartJun 1, 2002
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 23.7 years ago

Interventions

peginterferon alfa-2b (SCH 54031)biological

0.5 µg/kg subcutaneously once weekly for 60 months