BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | October 2014 |
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
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).
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).
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
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