CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 540 enrolled
Drug / intervention
peginterferon alfa-2b (SCH 54031)biological
Likely dose
Peginterferon alfa-2b 0.5 µg/kg subcutaneously once weekly for 36 monthsAI-extracted
Key inclusion· 2
  • ✓Age 18–65 years at enrollment in prior study P02370
  • ✓Nonresponder to PEG-Intron plus Rebetol in study P02370
Key exclusion· 4
  • ✕Did not participate in prior study P02370
  • ✕Decompensated liver disease that developed during P02370
  • ✕Malignancy that developed during P02370
  • ✕Substance abuse that developed during P02370

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

Search/NCT00049842
NCT00049842Phase 3Completed
CompareCT.gov

PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)

Merck Sharp & Dohme LLC·interventional·Posted Nov 15, 2002·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating peginterferon alfa-2b (SCH 54031) for Chronic Hepatitis C and Liver Fibrosis. Completed, enrolled 540 participants.

Detailed Summary

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).

Study Details

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

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2002
Enrollment StartOct 1, 2002
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 23.6 years ago

Interventions

peginterferon alfa-2b (SCH 54031)biological

0.5 µg/kg Weekly QW SC for 36 months