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

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ClinicalTrials.gov Identifier: NCT00035789

Recruitment Status : Completed

First Posted : May 6, 2002

Last Update Posted : April 14, 2011

Sponsor:

Information provided by:

Bristol-Myers Squibb

Study Description

Brief Summary:

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

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Entecavir

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00035789

Locations

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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
Local Investigator
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

Publications of Results:

Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, Goodman Z, DeHertogh D, Wilber R, Zink RC, Cross A, Colonno R, Fernandes L; BEHoLD AI463027 Study Group. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1011-20. Erratum in: N Engl J Med. 2006 Apr 27;354(17):1863.

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ClinicalTrials.gov Identifier:	NCT00035789
Other Study ID Numbers:	AI463-027
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 Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections	Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Entecavir Antiviral Agents Anti-Infective Agents

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