CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Pegylated interferon alfa 2b +1 moredrug
Likely dose
Pegylated interferon alfa 2b 1.5 mcg/kgfrom 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/NCT01364090
NCT01364090Phase 4Completed

A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection Drug Use

Kirby Institute·interventional·Posted Jun 2, 2011·Updated Nov 18, 2019

In Brief

A Phase 4 clinical trial evaluating Pegylated interferon alfa 2b and Ribavirin for Hepatitis C, Chronic. Completed, enrolled 93 participants across 17 sites in 7 countries.

Detailed Summary

This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Germany, Norway, Switzerland, United Kingdom

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2011
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.1 years ago

Interventions

Pegylated interferon alfa 2bdrug

Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirindrug

Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.