At a glance
ClinicalIndex Comparison RecordN/ACompleted· 290 enrolled
Drug / intervention
Debio 025 +3 moredrug
Likely dose
Not stated in 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.
A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
In Brief
A clinical study evaluating Debio 025, Peg-IFNα2a, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 290 participants across 40 sites in 7 countries.
Detailed Summary
The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesBelgium, France, Germany, Italy, Poland, Romania, Spain
CollaboratorsParexel
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedMar 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedMar 3, 2009
Enrollment StartJan 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.3 years ago
Interventions
Debio 025drug
Debio 025 supplied in soft gel capsules
Peg-IFNα2adrug
Peg-IFNα2a supplied in pre-filled syringes
Ribavirindrug
Ribavirin supplied in tablets
Debio 025 placebodrug
Debio 025 placebo supplied in soft gel capsules