CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 470 enrolled
Drug / intervention
Ribavirin (RBV) +8 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.

Search/NCT01732796
NCT01732796Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

Boehringer Ingelheim·interventional·Posted Nov 26, 2012·Updated Apr 18, 2016

In Brief

A Phase 3 clinical trial evaluating Ribavirin (RBV), BI 201335 (Faldaprevir), and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 470 participants across 101 sites in 14 countries.

Detailed Summary

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustria, Canada, France, Germany, Hungary, Ireland, Italy, Netherlands, Portugal, Romania, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2012
Enrollment StartDec 1, 2012
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.6 years ago

Interventions

Ribavirin (RBV)drug

24 weeks of active RBV

BI 201335 (Faldaprevir)drug

16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335

Ribavirin (RBV)drug

24 weeks of active RBV

BI 207127drug

24 weeks of BI 207127

BI 201335 (Faldaprevir)drug

24 weeks of BI 201335

Ribavirin (RBV)drug

16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin

BI 207127drug

16 weeks BI 207127 followed by 8 weeks placebo to BI 207127

Faldaprevir (BI 201335)drug

24 weeks of 201335

BI 207127drug

24 weeks of BI 207127