A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
Inclusion criteria:
Exclusion criteria:
Vaiparaiso, Indiana, United States
Chiba, Chiba, Japan
Gifu, Gifu, Japan
Izunokuni, Shizuoka, Japan
Kamakura, Kanagawa, Japan
Kofu, Yamanashi, Japan
Kurashiki, Okayama, Japan
Kurume, Fukuoka, Japan
Matsumoto, Nagano, Japan
Nagoya, Aichi, Japan
Namegata, Ibaraki, Japan
Nishinomiya, Hyogo, Japan
Ogaki, Gifu, Japan
Omura, Nagasaki, Japan
Omuta, Fukuoka, Japan
Osaka, Osaka, Japan
Sendai, Miyagi, Japan
Tanabe, Wakayama, Japan
Toyama,Toyama, Japan
Tsu, Mie, Japan
Tsuchiura, Ibaraki, Japan
Majadahonda-Madrid, Spain