CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
Combination of (a) pegylated interferon alfa-2b and (b) rebetoldrug
Likely dose
Combination of (a) pegylated interferon alfa-2b and (b) rebetol 150 microgramfrom 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/NCT00378599
NCT00378599Phase 3Completed
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PROTECT - Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy and Safety in Hepatitis C Recurrence Therapy

Merck Sharp & Dohme LLC·interventional·Posted Sep 20, 2006·Updated Apr 6, 2017

In Brief

A Phase 3 clinical trial evaluating Combination of (a) pegylated interferon alfa-2b and (b) rebetol for Liver Transplantation and 2 related conditions. Completed, enrolled 125 participants.

Detailed Summary

This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplantation, Hepatitis C, Chronic, Liver Cirrhosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2006
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.8 years ago

Interventions

Combination of (a) pegylated interferon alfa-2b and (b) rebetoldrug

1. Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks 2. 200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks