Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
NCT ID: NCT00065507
Last Updated: 2013-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
195 participants
INTERVENTIONAL
2003-08-31
2013-05-31
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
NONE
Study Groups
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A1
Entecavir (ETV)
Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized
A2
Adefovir (ADV)
Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
Interventions
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Entecavir (ETV)
Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized
Adefovir (ADV)
Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis B virus (HBV) viremia
Exclusion
* Alanine aminotransferase (ALT) \> 15 x upper limit of normal (ULN)
* Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Research And Education, Inc.
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
University Of Miami School Of Medicine
Miami, Florida, United States
Pediatric Gasteroenterology
Atlanta, Georgia, United States
Hawaii Medical Center East
Honolulu, Hawaii, United States
Indiana University Med Center
Indianapolis, Indiana, United States
The Cht Liver Research Center
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Henry Ford Health System Irb
Detroit, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center (Cpmc)
New York, New York, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Baylor University Medical Center
Dallas, Texas, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Mcguire Dvamc
Richmond, Virginia, United States
Local Institution
Porto Alegre - Rs, Rio Grande do Sul, Brazil
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Sao Paulo - Sp, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Clichy, , France
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Strasbourg, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Tai Po, , Hong Kong
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Hyderabad, Andhra Pradesh, India
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Kolkata, , India
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Lucknow, , India
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New Delhi, , India
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Jakarta, , Indonesia
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Cebu, , Philippines
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Manila, , Philippines
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Bydgoszcz, , Poland
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Chorzów, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Smolensk, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Observatory, Western Cape, South Africa
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Paarl, Western Cape, South Africa
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Changhua, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Tianan, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Adana, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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London, Greater London, United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI463-048
Identifier Type: -
Identifier Source: org_study_id
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