CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,428 enrolled
Drug / intervention
Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) +1 moredrug
Likely dose
Pegylated interferon alfa-2b 1.5 micrograms/kg subcutaneously weekly for 48 or 72 weeks, plus ribavirin 800-1400 mg orally daily for 48 or 72 weeksAI-extracted
Key inclusion· 7
  • ✓Age 18-70 years
  • ✓Genotype-1 HCV RNA positive
  • ✓Liver biopsy within 18 months confirming chronic hepatitis or cirrhosis
  • ✓Compensated liver disease with specified lab thresholds: Hgb ≥12 g/dL (females) or ≥13 g/dL (males); WBC ≥3000/mm³; neutrophils ≥1500/mm³; platelets ≥80,000/mm³
Key exclusion· 10
  • ✕Prior HCV antiviral or immunomodulating treatment of any kind
  • ✕Weight >125 kg
  • ✕HBV or HIV coinfection
  • ✕Other cause of liver disease (hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease, NASH, drug-related liver disease)

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

Search/NCT00265395
NCT00265395Phase 3Completed
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A Study to Assess Treatment With PEG-Intron® and Rebetol® in Naïve Patients With Genotype 1 Chronic Hepatitis C and Slow Virological Response

Merck Sharp & Dohme LLC·interventional·Posted Dec 14, 2005·Updated Apr 5, 2017

In Brief

A Phase 3 clinical trial evaluating Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) and Combination of pegylated interferon alfa-2b and ribavirin for Hepatitis C, Chronic. Completed, enrolled 1,428 participants.

Detailed Summary

This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2005
Enrollment StartDec 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.6 years ago

Interventions

Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)drug

1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks 2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks

Combination of pegylated interferon alfa-2b and ribavirindrug

1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks. 2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks