At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 131 enrolled
Drug / intervention
BI 201335 high dose +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.
Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
In Brief
A Phase 3 clinical trial evaluating BI 201335 high dose and BI 201335 low dose for Hepatitis C. Completed, enrolled 131 participants across 24 sites.
Detailed Summary
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedApr 18, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.2 years ago
Interventions
BI 201335 high dosedrug
BI 201335 high dose with PegIFN/RBV
BI 201335 low dosedrug
BI 201335 low dose with PegIFN/RBV
BI 201335 high dosedrug
BI 201335 high dose with PegIFN/RBV
BI 201335 high dosedrug
BI 201335 high dose with PegIFN/RBV