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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: BI 207127 high dose; Drug: Faldaprevir; Drug: BI 207127 low dose; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830127

1241.30

2012-003534-17 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

cohort A CPA

Experimental group

Description:

Cohort A CPA BI 207127/QD Faldaprevir Ribavirin

Treatment:

Drug: Ribavirin

Drug: Ribavirin

Drug: Faldaprevir

Drug: Faldaprevir

Drug: BI 207127 low dose

cohort A CPB

Experimental group

Description:

Cohort B CPB BI 207127/QD Faldaprevir Ribavirin

Treatment:

Drug: Ribavirin

Drug: Ribavirin

Drug: Faldaprevir

Drug: Faldaprevir

Drug: BI 207127 high dose