CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,081 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/NCT01318694
NCT01318694Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

Debiopharm International SA·interventional·Posted Mar 18, 2011·Updated Sep 30, 2016

In Brief

A Phase 3 clinical trial evaluating Alisporivir, Peginterferon alfa-2a, and 2 other interventions for Hepatitis C. Completed, enrolled 1,081 participants across 146 sites in 21 countries.

Detailed Summary

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesArgentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2011
Enrollment StartMar 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.3 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

ALV Placebodrug

ALV placebo soft gel capsules administered orally