CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 538 enrolled
Drug / intervention
PegIntron (peginterferon alfa-2b; SCH 54031) +1 morebiological
Likely dose
Rebetol (ribavirin; SCH 18908) 1200 mgfrom 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/NCT00709059
NCT00709059N/ACompleted
CompareCT.gov

A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)

Merck Sharp & Dohme LLC·observational·Posted Jul 3, 2008·Updated Nov 4, 2015

In Brief

An observational study evaluating PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908) for Hepatitis C, Chronic. Completed, enrolled 538 participants.

Detailed Summary

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

Study Details

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

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2008
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.0 years ago

Interventions

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

PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

Rebetol (ribavirin; SCH 18908)drug

Rebetol administered based on body weight 800-1200 mg/day (\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \>85 kg: 1200 mg) orally for 48 weeks