CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 459 enrolled
Drug / intervention
Alisporivir +3 moredrug
Likely dose
Alisporivir 200 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/NCT01183169
NCT01183169Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

Debiopharm International SA·interventional·Posted Aug 17, 2010·Updated Aug 25, 2016

In Brief

A Phase 2 clinical trial evaluating Alisporivir, Peginterferon alfa-2a, and 2 other interventions for Hepatitis C. Completed, enrolled 459 participants across 75 sites in 14 countries.

Detailed Summary

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, Belgium, France, Germany, Hungary, Italy, Poland, Puerto Rico, Romania, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.9 years ago

Interventions

Alisporivirdrug

ALV 200 mg soft gel capsules administered orally

Peginterferon alfa-2adrug

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

Ribavirindrug

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Placebodrug

ALV placebo soft gel capsules administered orally