At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 119 enrolled
Drug / intervention
BI 201335 +1 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, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) 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 and PegIFN/RBV for Hepatitis C. Completed, enrolled 119 participants across 87 sites in 15 countries.
Detailed Summary
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustria, Belgium, Canada, France, Germany, Japan, Portugal, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartJul 2011
Primary CompletionJun 2014
TodayJul 2026
First PostedApr 6, 2011
Enrollment StartJul 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.2 years ago
Interventions
BI 201335drug
BI 201335 for 24 weeks
PegIFN/RBVdrug
PegIFN/RBV for 48 weeks