Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
NCT ID: NCT00096785
Last Updated: 2010-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
2004-12-31
2008-04-30
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
NONE
Study Groups
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A1
entecavir
Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks
A2
adefovir
Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks
Interventions
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entecavir
Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks
adefovir
Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Compensated liver disease
16 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
San Diego, California, United States
Local Institution
San Francisco, California, United States
Local Institution
Torrance, California, United States
Local Institution
Miami, Florida, United States
Local Institution
North Miami Beach, Florida, United States
Local Institution
Baltimore, Maryland, United States
Local Insitution
New York, New York, United States
Local Institution
New York, New York, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Dallas, Texas, United States
Local Institution
Galveston, Texas, United States
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Chai Wan, , Hong Kong
Local Institution
Pokfulham, , Hong Kong
Local Institution
Tai Po, , Hong Kong
Local Institution
Jakarta, , Indonesia
Local Institution
Cebu, , Philippines
Local Institution
Manila, , Philippines
Local Institution
Singapore, , Singapore
Local Institution
Taichung, , Taiwan
Local Institution
Taoyan, , Taiwan
Local Institution
Bangkok, , Thailand
Countries
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References
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Leung N, Peng CY, Hann HW, Sollano J, Lao-Tan J, Hsu CW, Lesmana L, Yuen MF, Jeffers L, Sherman M, Min A, Mencarini K, Diva U, Cross A, Wilber R, Lopez-Talavera J. Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir. Hepatology. 2009 Jan;49(1):72-9. doi: 10.1002/hep.22658.
Other Identifiers
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AI463-079
Identifier Type: -
Identifier Source: org_study_id
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