CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 332 enrolled
Drug / intervention
PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b) +1 morebiological
Likely dose
PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b) 1.5 μgfrom 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/NCT00724464
NCT00724464N/ACompleted

A Greek Observational Study on Relapse Rate and Sustained Virological Response in Naive CHC Patients, Treated With Pegylated Interferon Alpha-2b and Ribavirin in Daily Clinical Practice

Merck Sharp & Dohme LLC·observational·Posted Jul 29, 2008·Updated Oct 19, 2015

In Brief

An observational study evaluating PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b) and Rebetol (ribavirin) for Hepatitis C, Chronic and Hepatitis C. Completed, enrolled 332 participants.

Detailed Summary

The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartDec 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)biological

Prior to enrollment in the study, PegIntron was to be administered at a dose of 1.5 μg/kg/week subcutaneously in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.

Rebetol (ribavirin)drug

Prior to enrollment in the study, Rebetol was to be administered at a dose of 800-1200 mg/day orally in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.