Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

Launched by BOEHRINGER INGELHEIM · Sep 24, 2009

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Eligibility criteria

• Inclusion criteria:
• • 1. Chronic hepatitis C infection of genotype 1
• • 2. Therapy-naïve to interferon, pegylated interferon, and ribavirin
• • 3. HCV viral load \> 100.000 IU/ml at screening
• • 4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
• • 5. Normal retinal finding on fundoscopy within 6 months prior to Day 1
• • 6. Age 18 to 70 years
• Exclusion criteria:
• • 1. HCV of mixed genotype (1/2, 1/3, and 1/4) .
• • 2. Patients who have been previously treated with at least one dose of any protease inhibitor
• • 3. Evidence of liver disease due to causes other than chronic HCV infection
• • 4. Positive for HIV-1 or HIV-2 antibodies
• • 5. Hepatitis B virus (HBV) infection
• • 6. Decompensated liver disease, or history of decompensated liver disease
• • 7. Active malignancy or history of malignancy within the last 5 years
• • 8. History of alcohol or drug abuse (except cannabis) within the past 12 months.
• • 9. Body Mass Index \< 18 or \> 35 kg/m2.
• • 10. Usage of any investigational drugs within 30 days prior to enrolment
• • 11. Alpha fetoprotein value \>100ng/mL at screening;
• • 12. Total bilirubin \> 1.5 x ULN with ratio of direct/indirect \> 1.
• • 13. ALT or AST level \> 10 x ULN