Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatments ribavirin, bi 207127 high dose, faldaprevir, bi 207127 low dose
Phase phase 2
Sponsor Boehringer Ingelheim
Start date April 2013
End date October 2014
Trial size 35 participants
Trial identifier NCT01830127, 1241.30, 2012-003534-17

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
ribavirin
24 Weeks
faldaprevir
24 Weeks
bi 207127 low dose
24 Weeks
(Experimental)
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
bi 207127 high dose
24 Weeks
ribavirin
24 Weeks
faldaprevir
24 Weeks

Primary Outcomes

Measure
SVR12: Plasma HCV RNA level less than 25 IU/mL at 12 weeks after End of Treatment
time frame: 12 weeks after End of Treatment

Secondary Outcomes

Measure
SVR4: Plasma HCV RNA level less than 25 IU/mL at 4 weeks after End of Treatment
time frame: 4 weeks after End of Treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion criteria: 1. Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response). 2. Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only. 3. Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan. Exclusion criteria: 1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening 2. Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases. 3. HIV infection 4. Patients who have been previously treated with an investigational or approved DAA

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.