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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00035633
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : April 14, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Entecavir Phase 3

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : December 2001
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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;
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00035633

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United States, Alabama
Local Investigator
Birmingham, Alabama, United States, 35294
United States, Arizona
Local Investigator
Tucson, Arizona, United States, 85724
United States, California
Local Investigator
La Jolla, California, United States, 92037
Local Investigator
Los Angeles, California, United States, 90048
Local Investigator
Orange, California, United States, 92868
Local Investigator
Palo Alto, California, United States, 94304
Local Institution
San Francisco, California, United States, 94115
Local Investigator
Torrance, California, United States, 90505
United States, Connecticut
Local Investigator
Farmington, Connecticut, United States, 06030
United States, Florida
Local Investigator
Miami, Florida, United States, 33136
United States, Georgia
Local Investigator
Atlanta, Georgia, United States, 30309
Local Investigator
Atlanta, Georgia, United States, 30322
United States, Hawaii
Local Investigator
Honolulu, Hawaii, United States, 96820
United States, Illinois
Local Investigator
Chicago, Illinois, United States, 60622
United States, Iowa
Local Investigator
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Local Investigator
Boston, Massachusetts, United States, 02111
Local Investigator
Worcester, Massachusetts, United States, 01655
United States, Michigan
Local Investigator
Ann Arbor, Michigan, United States, 48109
Local Investigator
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Local Investigator
St Paul, Minnesota, United States, 55114
United States, New York
Local Investigator
Manhasset, New York, United States, 11030
Local Investigator
New York, New York, United States, 10003
Local Investigator
New York, New York, United States, 10029
Local Investigator
New York, New York, United States, 10032
Local Investigator
Rochester, New York, United States, 14642
United States, North Carolina
Local Investigator
Charlotte, North Carolina, United States, 28203
United States, Ohio
Local Investigator
Cleveland, Ohio, United States, 44125
United States, Pennsylvania
Local Investigator
Philadelphia, Pennsylvania, United States, 19104
Local Investigator
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Investigator Meeting
Providence, Rhode Island, United States, 02908
United States, Tennessee
Local Investigator
Nashville, Tennessee, United States, 37211
United States, Texas
Local Investigator
Dallas, Texas, United States, 75235
United States, Virginia
Local Investigator
Fairfax, Virginia, United States, 22031
Local Investigator
Richmond, Virginia, United States, 23249
United States, Washington
Local Investigator
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Bristol-Myers Squibb
Publications of Results:
Layout table for additonal information Identifier: NCT00035633    
Other Study ID Numbers: AI463-022
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: January 2010
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents