BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).

Key facts

Study ID

NCT01830127

Run by

Boehringer Ingelheim

People needed

35

Starts

2013-04-01

Expected to finish

2014-10-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response).
• Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
• Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.

You may not qualify if…

• HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening
• Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
• HIV infection
• Patients who have been previously treated with an investigational or approved DAA

Where it is running

• 1241.30.10003 Boehringer Ingelheim Investigational Site — La Mesa, California, United States
• 1241.30.10007 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1241.30.10001 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1241.30.10012 Boehringer Ingelheim Investigational Site — West Palm Beach, Florida, United States
• 1241.30.10011 Boehringer Ingelheim Investigational Site — Arlington, Texas, United States
• 1241.30.10002 Boehringer Ingelheim Investigational Site — Norfolk, Virginia, United States
• 1241.30.49002 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1241.30.49004 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1241.30.49005 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1241.30.49008 Boehringer Ingelheim Investigational Site — Bonn, Germany
• 1241.30.49006 Boehringer Ingelheim Investigational Site — Frankfurt am Main, Germany
• 1241.30.49001 Boehringer Ingelheim Investigational Site — Hanover, Germany
• 1241.30.49003 Boehringer Ingelheim Investigational Site — Leipzig, Germany
• 1241.30.49007 Boehringer Ingelheim Investigational Site — Mainz, Germany
• 1241.30.34002 Boehringer Ingelheim Investigational Site — Barcelona, Spain
• 1241.30.34005 Boehringer Ingelheim Investigational Site — Barcelona, Spain
• 1241.30.34003 Boehringer Ingelheim Investigational Site — Madrid, Spain
• 1241.30.34001 Boehringer Ingelheim Investigational Site — Majadahonda (Madrid), Spain
• 1241.30.44002 Boehringer Ingelheim Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

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