A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
NCT ID: NCT00035633
Last Updated: 2011-04-14
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
INTERVENTIONAL
2001-12-31
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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TREATMENT
Interventions
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Entecavir
Eligibility Criteria
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Inclusion Criteria
* Documentation of positive Hepatitis B e antigen (HBeAg) status.;
* The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
* The absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
* Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Local Investigator
Birmingham, Alabama, United States
Local Investigator
Tucson, Arizona, United States
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La Jolla, California, United States
Local Investigator
Los Angeles, California, United States
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Orange, California, United States
Local Investigator
Palo Alto, California, United States
Local Institution
San Francisco, California, United States
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Torrance, California, United States
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Farmington, Connecticut, United States
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Miami, Florida, United States
Local Investigator
Atlanta, Georgia, United States
Local Investigator
Atlanta, Georgia, United States
Local Investigator
Honolulu, Hawaii, United States
Local Investigator
Chicago, Illinois, United States
Local Investigator
Iowa City, Iowa, United States
Local Investigator
Boston, Massachusetts, United States
Local Investigator
Worcester, Massachusetts, United States
Local Investigator
Ann Arbor, Michigan, United States
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Royal Oak, Michigan, United States
Local Investigator
Saint Paul, Minnesota, United States
Local Investigator
Manhasset, New York, United States
Local Investigator
New York, New York, United States
Local Investigator
New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
Local Investigator
Pittsburgh, Pennsylvania, United States
Investigator Meeting
Providence, Rhode Island, United States
Local Investigator
Nashville, Tennessee, United States
Local Investigator
Dallas, Texas, United States
Local Investigator
Fairfax, Virginia, United States
Local Investigator
Richmond, Virginia, United States
Local Investigator
Seattle, Washington, United States
Countries
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References
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Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1001-10. doi: 10.1056/NEJMoa051285.
Other Identifiers
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AI463-022
Identifier Type: -
Identifier Source: org_study_id
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