A Phase II Dose Response Study in Japan in Chronic Hepatitis B
NCT ID: NCT01022801
Last Updated: 2010-02-02
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
120 participants
INTERVENTIONAL
2003-08-31
2005-03-31
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 (0.01 mg)
Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Entecavir (0.1 mg)
Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Entecavir (0.5 mg)
Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Interventions
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Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive for HBeAg OR negative for HBeAg with positive HBeAb,
* Documented HBV Viremia on 2 or more occasions: Viremia on sample drawn AND HBV DNA of ≥ 40 MEq/mL by Quantiplex assay at the screening visit
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
Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-047
Identifier Type: -
Identifier Source: org_study_id
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