CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 614 enrolled
Drug / intervention
Peginterferon alfa-2b (PegIntron) +2 morebiological
Likely dose
Peginterferon alfa-2b (PegIntron) 0.3 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/NCT00723892
NCT00723892N/ACompleted

Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program

Merck Sharp & Dohme LLC·observational·Posted Jul 29, 2008·Updated Oct 30, 2015

In Brief

An observational study evaluating Peginterferon alfa-2b (PegIntron), Rebetol (Ribavirin), and 1 other intervention for Hepatitis C, Chronic and Hepacivirus. Completed, enrolled 614 participants.

Detailed Summary

Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Study Details

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

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartJul 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.9 years ago

Interventions

Peginterferon alfa-2b (PegIntron)biological

Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg\^kg\^week

Rebetol (Ribavirin)drug

Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day

Psychotherapy support programbehavioral

Each site has implemented a psychotherapy support program.