An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Previous Phase II Studies in Japan But Who Require Further Treatment
An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Previous Phase II Studies in Japan But Who Require Further Treatment
To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
Inclusion Criteria:
Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
ALT ≤ 10 x upper limit of normal;
Subjects must have well-compensated liver disease according to ALL of the following criteria;
Exclusion Criteria:
Aichi-Gun, Aichi-ken 480-1195, Japan
Onsen-Gun, Ehime 791-0204, Japan
Ogaki-Shi, Gifu 503-8502, Japan
Fukuyama-Shi, Hiroshima 721-0971, Japan
Asahikawa-Shi, Hokkaido 070-0054, Japan
Akashi-Shi, Hyōgo 673-0848, Japan
Mitoyo-Gun, Kagawa-ken 769-1601, Japan
Miyazaki-Gun, Miyazaki 889-1692, Japan
Omura-Shi, Nagasaki 856-0000, Japan
Oita-Gun, Oita Prefecture 879-5503, Japan
Kurashiki-Shi, Okayama-ken 710-8602, Japan
Tsuyama-Shi, Okayama-ken 708-0841, Japan
Kawachinagano-Shi, Osaka 86-0008, Japan
Sakai-Shi, Osaka 591-8025, Japan
Suita-Shi, Osaka, Japan
Iruma-Gun, Saitama 350-0495, Japan
Minato-Ku, Tokyo 105-0001, Japan
Musashino-Shi, Tokyo 180-0023, Japan
Shinjuku-Ku, Tokyo 160-8582, Japan
Shinjuku-Ku, Tokyo 162-8655, Japan
Shinjuku-Ku, Tokyo 162-8666, Japan
Ube-Shi, Yamaguchi 755-0067, Japan
Nakakoma-Gun, Yamanashi 409-3821, Japan