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
PHASE3
288 participants
INTERVENTIONAL
2010-02-28
2011-05-31
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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1
Clevudine
Clevudine flexible dosages of 30 mg/day
2
Adefovir
Adefovir flexible dosages of 10 mg/day
Interventions
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Clevudine
Clevudine flexible dosages of 30 mg/day
Adefovir
Adefovir flexible dosages of 10 mg/day
Eligibility Criteria
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Exclusion Criteria
2. Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
3. Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
4. Poorly controlled type I or type 2 diabetes mellitus
5. Donation or loss more than 400 ml blood within 60 days of baseline.
6. Known serious allergies to nucleoside/nucleotide analogs.
7. Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.
18 Years
65 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Guoping Yang
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital
Locations
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Xiangya hospital
Changsha, Hunan, China
Countries
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Other Identifiers
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XY3-III-CLV-1001A02.4
Identifier Type: -
Identifier Source: org_study_id
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