Phase 2
Completed N=35
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01830127 ↗
Enrolled (actual)
35
Serious AEs
28.6%
Results posted
Nov 2015
Primary outcomePrimary: SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) — 61.1; 52.9 Percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) |
61.1; 52.9 | — |
| SECONDARY SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT) |
72.2; 76.5 | — |
Eligibility Criteria
Inclusion criteria
- Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response).
- Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
- Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.
Exclusion criteria
- 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
- 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.
- HIV infection
- Patients who have been previously treated with an investigational or approved DAA
Data sourced from ClinicalTrials.gov (NCT01830127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.