NCT01728324

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI 207127-placebo: 8-week treatment	8 weeks of placebo treatment
DRUG	Ribavirin: 24-week treatment	24 weeks of active treatment
DRUG	BI 207127: 24-week treatment	24 weeks of active treatment
DRUG	Faldaprevir: 24-week treatment	24 weeks of active treatment
DRUG	Faldaprevir: 24-week treatment	24 weeks of active treatment
DRUG	Ribavirin-placebo: 8-week treatment	8 weeks of placebo treatment
DRUG	BI 207127: 24-week treatment	24 weeks of active treatment
DRUG	Faldaprevir-placebo: 8-week treatment	8 weeks of placebo treatment
DRUG	Faldaprevir: 16-week treatment	16 weeks of active treatment
DRUG	Ribavirin: 16-week treatment	16 weeks of active treatment
DRUG	RBV: 24-week treatment	24 weeks of active treatment
DRUG	BI 207127: 16-week treatment	16 weeks of active treatment

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-02-01
• Completion: 2015-01-01
• First posted: 2012-11-19
• Last updated: 2016-02-12
• Results posted: 2016-02-12

Locations

109 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Greece, Italy, New Zealand, Portugal, Spain, United Kingdom