Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy
NCT ID: NCT01037166
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
84 participants
INTERVENTIONAL
2002-12-31
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Entecavir (0.5 mg)
Entecavir
Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
Entecavir (1mg)
Entecavir
Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
Interventions
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Entecavir
Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy
2. Patient who have received lamivudine therapy for 24 weeks or more, or patient who have documented YMDD mutation or other lamivudine-resistant mutation while on lamivudine
3. Documented HBV Viremia ≥ 10\*5: copies/mL
* ALT in the range of 1.3 to 10 x ULN
* Subjects must have well-compensated liver disease a) value
Exclusion Criteria
20 Years
75 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
Chiba, Chiba, Japan
Local Institution
Kurume, Fukuoka, Japan
Local Institution
Ogaki-Shi, Gifu, Japan
Local Institution
Asahikawa-Shi, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Akashi-Shi, Hyōgo, Japan
Local Institution
Morioka, Iwate, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Minato-Ku, Tokyo, Japan
Local Institution
Musashino-Shi, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Countries
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References
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Suzuki F, Toyoda J, Katano Y, Sata M, Moriyama M, Imazeki F, Kage M, Seriu T, Omata M, Kumada H. Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients. J Gastroenterol Hepatol. 2008 Sep;23(9):1320-6. doi: 10.1111/j.1440-1746.2008.05455.x. Epub 2008 Jun 28.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-052
Identifier Type: -
Identifier Source: org_study_id