NCT00774397

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 719 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Placebo

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-11-01
• First posted: 2008-10-17
• Last updated: 2015-11-16
• Results posted: 2015-11-16

Locations

100 sites across 15 countries: United States, Argentina, Australia, Austria, Canada, Czechia, France, Germany, Netherlands, Portugal, Romania, South Korea, Spain, Switzerland, United Kingdom