At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 678 enrolled
Drug / intervention
BI 201335 +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 Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
In Brief
A Phase 3 clinical trial evaluating BI 201335, Pegylated Interferon-alpha (IFN), and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 678 participants across 116 sites in 12 countries.
Detailed Summary
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustria, Belgium, Canada, France, Germany, Japan, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionFeb 2013
Study CompletionMay 2014
TodayJul 2026
First PostedMay 24, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.1 years ago
Interventions
BI 201335drug
BI 201335 once a day (QD) for 24 weeks
Pegylated Interferon-alpha (IFN)drug
Pegylated Interferon-alpha for 48 weeks
Ribavirin (RBV)drug
Ribavirin (RBV) for 24 or 48 weeks
Placebodrug
Placebo to BI201335 for 24 weeks