At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 658 enrolled
Drug / intervention
BI201335 +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, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
In Brief
A Phase 3 clinical trial evaluating BI201335, PegIFN/RBV, and 1 other intervention for Hepatitis C. Completed, enrolled 658 participants across 106 sites in 5 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
CountriesCanada, Puerto Rico, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartApr 2011
Primary CompletionApr 2014
TodayJul 2026
First PostedFeb 16, 2011
Enrollment StartApr 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.4 years ago
Interventions
BI201335drug
QD BI 201335
PegIFN/RBVdrug
BI201335drug
QD (once daily) BI 201335
Placebodrug