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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
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.
Time frame: 12 weeks after End of Treatment
SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
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.
Time frame: 4 weeks after End of Treatment
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24 Weeks
24 Weeks
24 Weeks
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
...and 9 more locations