An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection
NCT ID: NCT01037062
Last Updated: 2011-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2003-12-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Entecavir
Entecavir
Tablet, P.O. 0.5, 1 mg, once daily
Interventions
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Entecavir
Tablet, P.O. 0.5, 1 mg, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ALT ≤ 10 x upper limit of normal;
* Subjects must have well-compensated liver disease according to ALL of the following criteria;
1. Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
2. Serum albumin ≥ 3 g/dL (≥ 30 g/L)
3. Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)
Exclusion Criteria
* Target Disease Exceptions
* Medical History and Concurrent Diseases
20 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Aichi-Gun, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Chiba, Chiba, Japan
Local Institution
Onsen-Gun, Ehime, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kurume, Fukuoka, Japan
Local Institution
Gifu, Gifu, Japan
Local Institution
Ogaki-Shi, Gifu, Japan
Local Institution
Fukuyama-Shi, Hiroshima, Japan
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Asahikawa-Shi, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Akashi-Shi, Hyōgo, Japan
Local Institution
Morioka, Iwate, Japan
Local Institution
Mitoyo-Gun, Kagawa-ken, Japan
Local Institution
Takamatsu, Kagawa-ken, Japan
Local Institution
Kumamoto, Kumamoto, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Miyazaki-Gun, Miyazaki, Japan
Local Institution
Matsumoto, Nagano, Japan
Local Institution
Nagasaki, Nagasaki, Japan
Local Institution
Omura-Shi, Nagasaki, Japan
Local Institution
Niigata, Niigata, Japan
Local Institution
Oita-Gun, Oita Prefecture, Japan
Local Institution
Kurashiki-Shi, Okayama-ken, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Tsuyama-Shi, Okayama-ken, Japan
Local Institution
Kawachinagano-Shi, Osaka, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Sakai-Shi, Osaka, Japan
Local Institution
Suita-Shi, Osaka, Japan
Local Institution
Iruma-Gun, Saitama, Japan
Local Institution
Minato-Ku, Tokyo, Japan
Local Institution
Musashino-Shi, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Tokyo, Tokyo, Japan
Local Institution
Ube-Shi, Yamaguchi, Japan
Local Institution
Nakakoma-Gun, Yamanashi, Japan
Countries
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References
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Yokosuka O, Takaguchi K, Fujioka S, Shindo M, Chayama K, Kobashi H, Hayashi N, Sato C, Kiyosawa K, Tanikawa K, Ishikawa H, Masaki N, Seriu T, Omata M. Long-term use of entecavir in nucleoside-naive Japanese patients with chronic hepatitis B infection. J Hepatol. 2010 Jun;52(6):791-9. doi: 10.1016/j.jhep.2009.12.036. Epub 2010 Mar 24.
Karino Y, Toyota J, Kumada H, Katano Y, Izumi N, Kobashi H, Sata M, Moriyama M, Imazeki F, Kage M, Ishikawa H, Masaki N, Seriu T, Omata M. Efficacy and resistance of entecavir following 3 years of treatment of Japanese patients with lamivudine-refractory chronic hepatitis B. Hepatol Int. 2010 Feb 6;4(1):414-22. doi: 10.1007/s12072-009-9162-x.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-060
Identifier Type: -
Identifier Source: org_study_id