Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: BI 201335 NA 240 mg QD / LI; PegIFN/RBV; BI 201335 NA 120mg QD / LI; PegIFN/RBV; BI 201335 NA 240 mg QD; PegIFN/RBV; BI 201335 NA 240 mg QD; PegIFN/RBV; BI 201335 NA 240 mg BID; PegIFN/RBV; PegIFN/RBV; BI 201335 NA 240 mg QD; PegIFN/RBV; Placebo
Intervention description: 240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks; 120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks; 240mg BI 201335 NA (Faldaprevir) twice, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 719.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI
      201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus
      (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated
      interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed
      in treatment-naïve (TN) and treatment experienced (TE) patients.
    

Eligibility criteria:

        Inclusion criteria:

        chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL >=100,000 IU/mL Liver biopsy
        within 2 years prior to study enrolment showing necroinflammatory activity or presence of
        fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65
        years Females and males with adequate contraception

        Exclusion criteria:

        Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous
        treatment with protease inhibitor Evidence of liver disease due to causes other than
        chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or
        history of decompensated liver disease Active or suspected malignancy or history of
        malignancy within the last 5 years History of alcohol or drug abuse within the past 12
        months. Usage of any investigational drug within 30 days prior to enrolment, or 5
        half-lives, whichever is longer Known hypersensitivity to any ingredient of the study drugs
        Condition that is defined as one which in the opinion of the investigator may put the
        patient at risk because of participation in the study or may influence the results of the
        study or the patient's ability to participate in the study Alpha-fetoprotein value >
        100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no
        evidence of liver cancer in two congruent imaging studies Total bilirubin > 1.5x ULN wiht
        ratio of direct/indirect >1. ALT or AST levels > 5x ULN INR prolonged to >1.5x ULN
        Exclusion criteria related to PegIFN and/or RBV restrictions.