At a glance
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A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
In Brief
A Phase 3 clinical trial evaluating BI 207127-placebo: 8-week treatment, Ribavirin: 24-week treatment, and 8 other interventions for Hepatitis C, Chronic. Completed, enrolled 496 participants across 109 sites in 12 countries.
Detailed Summary
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Study Details
Timeline
Interventions
8 weeks of placebo treatment
24 weeks of active treatment
24 weeks of active treatment
24 weeks of active treatment
24 weeks of active treatment
8 weeks of placebo treatment
24 weeks of active treatment
8 weeks of placebo treatment
16 weeks of active treatment
16 weeks of active treatment
24 weeks of active treatment
16 weeks of active treatment