Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: BI 207127-placebo: 8-week treatment; Ribavirin: 24-week treatment; BI 207127: 24-week treatment; Faldaprevir: 24-week treatment; Faldaprevir: 24-week treatment; Ribavirin-placebo: 8-week treatment; BI 207127: 24-week treatment; Faldaprevir-placebo: 8-week treatment; Faldaprevir: 16-week treatment; Ribavirin: 16-week treatment; RBV: 24-week treatment; BI 207127: 16-week treatment
Intervention description: 8 weeks of placebo treatment; 24 weeks of active treatment; 24 weeks of active treatment; 24 weeks of active treatment; 24 weeks of active treatment; 8 weeks of placebo treatment; 24 weeks of active treatment; 8 weeks of placebo treatment; 16 weeks of active treatment; 16 weeks of active treatment; 24 weeks of active treatment; 16 weeks of active treatment
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 496.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI
      207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
    

Eligibility criteria:

        Inclusion criteria:

          1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected
             HCV RNA at screening

          2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.

          3. HCV viral load =1,000 IU/mL at randomisation.

          4. Patients who have never been previously treated with any other HCV treatment regimen.

        Exclusion criteria:

          1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at
             screening.

          2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.

          3. Liver disease due to causes other than chronic HCV infection.

          4. HIV infection.

          5. Hepatitis B virus infection based on presence of HBs-Ag.

          6. Confirmed or suspected active malignancy or history of malignancy within the last 5
             years prior to screening.

          7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12
             months prior to randomisation.

          8. Subject is not willing to comply with the precautionary measures to prevent
             photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).

          9. Decompensated liver disease, or history of decompensated liver disease.

         10. Clinical evidence of unstable cardiovascular disease which may further decompensate
             due to anemia.

         11. Red blood cell disorders.

         12. Body weight <40 kg or >125 kg.