BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01830127
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cohort A CPA Ribavirin Cohort A CPA BI 207127/QD Faldaprevir Ribavirin cohort A CPA BI 207127 low dose Cohort A CPA BI 207127/QD Faldaprevir Ribavirin cohort A CPB BI 207127 high dose Cohort B CPB BI 207127/QD Faldaprevir Ribavirin cohort A CPB Faldaprevir Cohort B CPB BI 207127/QD Faldaprevir Ribavirin cohort A CPB Ribavirin Cohort B CPB BI 207127/QD Faldaprevir Ribavirin cohort A CPA Faldaprevir Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
- Primary Outcome Measures
Name Time Method SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) 12 weeks after End of Treatment Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
- Secondary Outcome Measures
Name Time Method SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT) 4 weeks after End of Treatment Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.
Trial Locations
- Locations (19)
1241.30.10001 Boehringer Ingelheim Investigational Site
🇺🇸Deland, Florida, United States
1241.30.49004 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1241.30.49008 Boehringer Ingelheim Investigational Site
🇩🇪Bonn, Germany
1241.30.49001 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1241.30.49003 Boehringer Ingelheim Investigational Site
🇩🇪Leipzig, Germany
1241.30.44002 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1241.30.34001 Boehringer Ingelheim Investigational Site
🇪🇸Majadahonda (Madrid), Spain
1241.30.49005 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1241.30.34002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1241.30.34003 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1241.30.49007 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1241.30.10012 Boehringer Ingelheim Investigational Site
🇺🇸West Palm Beach, Florida, United States
1241.30.10007 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1241.30.10003 Boehringer Ingelheim Investigational Site
🇺🇸La Mesa, California, United States
1241.30.10011 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
1241.30.10002 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
1241.30.49006 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1241.30.49002 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1241.30.34005 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain