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

Condition(s) targeted: Chronic Hepatitis B

Intervention: Entecavir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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.

Study design: Treatment

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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)

Local Investigator, Birmingham, Alabama, United States

Local Investigator, Tucson, Arizona, United States

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 90048, United States

Local Investigator, Farmington, Connecticut, United States

Local Investigator, Miami Beach, Florida, United States

Local Investigator, Atlanta, Georgia 30322, United States

Local Investigator, Honolulu, Hawaii, United States

Local Investigator, Chicago, Illinois 60622, United States

Local Investigator, Iowa City, Iowa, United States

Local Investigator, Kansas City, Kansas, United States

Local Investigator, Dundalk, Maryland, United States

Local Investigator, Worcester, Massachusetts, United States

Local Investigator, Royal Oak, Michigan, United States

Local Investigator, Ann Arbor, Michigan, United States

Local Investigator, St. Paul, Minnesota, United States

Local Investigator, New York, New York, United States

Local Investigator, Rochester, New York, United States

Local Investigator, Manhasset, New York, United States

Local Investigator, Charlotte, North Carolina, United States

Local Investigator, Cleveland, Ohio, United States

Local Investigator, Pittsburgh, Pennsylvania, United States

Local Investigator, Philadelphia, Pennsylvania, United States

Local Investigator, Providence, Rhode Island, United States

Local Investigator, Nashville, Tennessee 37211, United States

Local Investigator, Dallas, Texas, United States

Local Investigator, Richmond, Virginia, United States

Local Investigator, Fairfax, Virginia, United States

Local Investigator, Seattle, Washington, United States

BMS Clinical Trials Disclosure

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

Last updated: August 22, 2007