NCT01830127

BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Ribavirin	24 Weeks
DRUG	BI 207127 high dose	24 Weeks
DRUG	Faldaprevir	24 Weeks
DRUG	Ribavirin	24 Weeks
DRUG	BI 207127 low dose	24 Weeks
DRUG	Faldaprevir	24 Weeks

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-04-12
• Last updated: 2015-11-20
• Results posted: 2015-11-20

Locations

19 sites across 4 countries: United States, Germany, Spain, United Kingdom