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