This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

Inclusion criteria:

• Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:

  1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
  2. liver biopsy consistent with chronic HCV infection.

• HCV infection of genotype 1 confirmed by genotypic testing at screening

• Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.

• Plasma HCV RNA = 100,000 IU/mL at screening

Exclusion criteria:

• Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
• Human immunodeficiency virus (HIV) co-infection
• Decompensated liver disease, or history of decompensated liver disease
• Body weight < 40 or > 125 kg at screening
• Hemoglobin <12.0g/dL for women and <13.0g/dL for men at screening
• White blood cell count <3000 cells/mm3 at screening
• Absolute neutrophil count < 1,500 cells/mm3 at screening
• Platelet count < 90,000 /mm3 at screening
• Serum creatinine > 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening