Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
NCT00774397 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 719
Last updated 2015-11-16
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.
Conditions
- Hepatitis C, Chronic
Interventions
- DRUG
-
BI 201335 NA 240 mg QD / LI
240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
- DRUG
-
BI 201335 NA 120mg QD / LI
120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
- DRUG
-
BI 201335 NA 240 mg QD
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
- DRUG
-
BI 201335 NA 240 mg QD
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
- DRUG
-
BI 201335 NA 240 mg BID
240mg BI 201335 NA (Faldaprevir) twice, 24 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
- DRUG
-
BI 201335 NA 240 mg QD
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
- DRUG
-
PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
- DRUG
-
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2011-11-30
Countries
- United States
- Argentina
- Australia
- Austria
- Canada
- Czechia
- France
- Germany
- Netherlands
- Portugal
- Romania
- South Korea
- Spain
- Switzerland
- United Kingdom
Study Locations
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