CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 340 enrolled
Drug / intervention
Alisporivir +2 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/NCT01215643
NCT01215643Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

Debiopharm International SA·interventional·Posted Oct 6, 2010·Updated Aug 30, 2016

In Brief

A Phase 2 clinical trial evaluating Alisporivir, Peginterferon alfa-2a, and 1 other intervention for Hepatitis C and Chronic Pain. Completed, enrolled 340 participants across 73 sites in 14 countries.

Detailed Summary

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic Pain
CountriesAustralia, Belgium, Canada, France, Germany, India, Italy, Poland, Puerto Rico, South Korea, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.7 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 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)