At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 656 enrolled
Drug / intervention
PegIFN/RBV +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 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
In Brief
A Phase 3 clinical trial evaluating PegIFN/RBV, BI 201335, and 1 other intervention for Hepatitis C. Completed, enrolled 656 participants across 98 sites in 11 countries.
Detailed Summary
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustria, Belgium, France, Germany, Japan, Portugal, Romania, Russia, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionMar 2014
TodayJul 2026
First PostedApr 28, 2011
Enrollment StartApr 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.2 years ago
Interventions
PegIFN/RBVdrug
PegIFN/RBV for 48 weeks
BI 201335drug
BI 201335 once daily high dose
BI 201335drug
BI 201335 once daily low dose
Placebodrug