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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035789

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Entecavir

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035789

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Locations

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
San Francisco, California, United States
Local Investigator
Orange, California, United States
Local Investigator
Los Angeles, California, United States, 90048
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
Royal Oak, Michigan, United States
Local Investigator
Ann Arbor, Michigan, United States
United States, Minnesota
Local Investigator
St. Paul, Minnesota, United States
United States, New York
Local Investigator
New York, New York, United States
Local Investigator
Rochester, New York, United States
Local Investigator
Manhasset, 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
Pittsburgh, Pennsylvania, United States
Local Investigator
Philadelphia, 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
Richmond, Virginia, United States
Local Investigator
Fairfax, Virginia, United States
United States, Washington
Local Investigator
Seattle, Washington, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	AI463-027
Study First Received:	May 5, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00035789 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Hepatitis

Virus Diseases
Digestive System Diseases
Entecavir
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on November 30, 2009