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A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: May 5, 2002
Last updated: April 7, 2011
Last verified: January 2010
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.

Condition Intervention Phase
Chronic Hepatitis B
Drug: Entecavir
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Study Start Date: November 2001
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;
  • HBeAg negative, anti-HBeAb positive;
  • Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
  • 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)
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Please refer to this study by its identifier: NCT00035789

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United States, Alabama
Local Investigator
Birmingham, Alabama, United States
United States, Arizona
Local Investigator
Tucson, Arizona, United States
United States, California
Local Investigator
La Jolla, California, United States
Local Investigator
Los Angeles, California, United States, 90048
Local Investigator
Orange, California, United States
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San Francisco, California, United States
United States, Connecticut
Local Investigator
Farmington, Connecticut, United States
United States, Florida
Local Investigator
Miami Beach, Florida, United States
United States, Georgia
Local Investigator
Atlanta, Georgia, United States, 30322
United States, Hawaii
Local Investigator
Honolulu, Hawaii, United States
United States, Illinois
Local Investigator
Chicago, Illinois, United States, 60622
United States, Iowa
Local Investigator
Iowa City, Iowa, United States
United States, Kansas
Local Investigator
Kansas City, Kansas, United States
United States, Maryland
Local Investigator
Dundalk, Maryland, United States
United States, Massachusetts
Local Investigator
Worcester, Massachusetts, United States
United States, Michigan
Local Investigator
Ann Arbor, Michigan, United States
Local Investigator
Royal Oak, Michigan, United States
United States, Minnesota
Local Investigator
St. Paul, Minnesota, United States
United States, New York
Local Investigator
Manhasset, New York, United States
Local Investigator
New York, New York, United States
Local Investigator
Rochester, New York, United States
United States, North Carolina
Local Investigator
Charlotte, North Carolina, United States
United States, Ohio
Local Investigator
Cleveland, Ohio, United States
United States, Pennsylvania
Local Investigator
Philadelphia, Pennsylvania, United States
Local Investigator
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Local Investigator
Providence, Rhode Island, United States
United States, Tennessee
Local Investigator
Nashville, Tennessee, United States, 37211
United States, Texas
Local Investigator
Dallas, Texas, United States
United States, Virginia
Local Investigator
Fairfax, Virginia, United States
Local Investigator
Richmond, Virginia, United States
United States, Washington
Local Investigator
Seattle, Washington, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
Publications: Identifier: NCT00035789     History of Changes
Other Study ID Numbers: AI463-027
Study First Received: May 5, 2002
Last Updated: April 7, 2011

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents processed this record on April 24, 2017