A Study in Japan of the Safety and Antiviral Activity With Chronic Hepatitis B Infection
NCT ID: NCT01020565
Last Updated: 2010-08-06
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
60 participants
INTERVENTIONAL
2003-02-28
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 (0.1 mg)
Entecavir
Tablet, P.O., 0.1 OR 0.5 mg, once daily, 52 weeks
Entecavir (0.5 mg)
Entecavir
Tablet, P.O., 0.1 OR 0.5 mg, once daily, 52 weeks
Interventions
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Entecavir
Tablet, P.O., 0.1 OR 0.5 mg, 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. Positive for HBeAg OR negative for HBeAg
3. Documented HBV Viremia on 2 or more occasions and at screening visit: Viremia on sample drawn AND HBV DNA of ≥ 10\*5\* copies/mL by PCR assay at the screening visit
* ALT in the range of 1.3 to 10 x ULN
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
References
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Kobashi H, Takaguchi K, Ikeda H, Yokosuka O, Moriyama M, Imazeki F, Kage M, Seriu T, Omata M, Sakaguchi K, Shiratori Y. Efficacy and safety of entecavir in nucleoside-naive, chronic hepatitis B patients: phase II clinical study in Japan. J Gastroenterol Hepatol. 2009 Feb;24(2):255-61. doi: 10.1111/j.1440-1746.2008.05593.x.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-053
Identifier Type: -
Identifier Source: org_study_id
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