CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,469 enrolled
Drug / intervention
PegIntron (peginterferon alfa-2b; SCH 54031) +4 morebiological
Likely dose
PegIntron 1.5 µg/kg/week or 1.0 µg/kg/week subcutaneously plus REBETOL 800-1400 mg/day orally, OR PEGASYS 180 µg/week subcutaneously plus COPEGUS 1000-1200 mg/day orally, all for 48 weeksAI-extracted
Key inclusion· 8
  • ✓Previously untreated adults with chronic hepatitis C and quantifiable HCV RNA
  • ✓HCV genotype 1 infection (including mixed 1a/1b)
  • ✓Compensated liver disease
  • ✓Age 18-70 years
Key exclusion· 17
  • ✕Any prior hepatitis C treatment
  • ✕Pregnant women, breastfeeding women, or plans to become pregnant during 48 weeks of treatment
  • ✕Hepatitis B or HIV co-infection
  • ✕Liver disease not caused by hepatitis C or history of hepatocellular carcinoma

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

Search/NCT00081770
NCT00081770Phase 3Completed
CompareCT.gov

Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1

Merck Sharp & Dohme LLC·interventional·Posted Apr 22, 2004·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908), and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 4,469 participants.

Detailed Summary

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Study Details

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

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2004
Enrollment StartMar 1, 2004
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 22.2 years ago

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)biological

1.5 ug/kg/week subcutaneously (SC) for 48 weeks

PegIntron (peginterferon alfa-2b; SCH 54031)biological

1.0 ug/kg/week SC for 48 weeks

REBETOL (ribavirin; SCH 18908)drug

weight based dose 800-1400 mg/day orally (PO) for 48 weeks

PEGASYS (peginterferon alfa-2a)biological

180 ug/week SC administered for 48 weeks

COPEGUS (ribavirin)drug

1000-1200 mg/day PO for 48 weeks