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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00774397

Run by

Boehringer Ingelheim

People needed

719

Starts

2008-10-01

Last updated by the study team

2015-11-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 1220.5.0008 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 1220.5.0005 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1220.5.0006 Boehringer Ingelheim Investigational Site — Lutherville, Maryland, United States
• 1220.5.0002 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1220.5.0003 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1220.5.0007 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1220.5.0010 Boehringer Ingelheim Investigational Site — Germantown, Tennessee, United States
• 1220.5.0009 Boehringer Ingelheim Investigational Site — Nashville, Tennessee, United States
• 1220.5.0004 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1220.5.5401 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1220.5.5403 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1220.5.5405 Boehringer Ingelheim Investigational Site — Derqui, Pilar, Argentina
• 1220.5.5402 Boehringer Ingelheim Investigational Site — Rosario, Argentina
• 1220.5.5406 Boehringer Ingelheim Investigational Site — Rosario, Argentina
• 1220.5.6110 Boehringer Ingelheim Investigational Site — Camperdown, New South Wales, Australia
• 1220.5.6109 Boehringer Ingelheim Investigational Site — Kogarah, New South Wales, Australia
• 1220.5.6105 Boehringer Ingelheim Investigational Site — Randwick, New South Wales, Australia
• 1220.5.6101 Boehringer Ingelheim Investigational Site — Westmead, New South Wales, Australia
• 1220.5.6103 Boehringer Ingelheim Investigational Site — Herston, Queensland, Australia
• 1220.5.6104 Boehringer Ingelheim Investigational Site — Woolloongabba, Queensland, Australia
• 1220.5.6102 Boehringer Ingelheim Investigational Site — Clayton, Victoria, Australia
• 1220.5.6107 Boehringer Ingelheim Investigational Site — Fitzroy, Victoria, Australia
• 1220.5.6108 Boehringer Ingelheim Investigational Site — Parkville, Victoria, Australia
• 1220.5.4303 Boehringer Ingelheim Investigational Site — Linz, Austria
• 1220.5.0001 Boehringer Ingelheim Investigational Site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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