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

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035789
• Other study ID #: AI463-027
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2002
• Last updated: April 7, 2011
• Start date: November 2001
• Est. completion date: May 2005

Study information

• Verified date: January 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

• 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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir

Locations

Country	Name	City	State
United States	Local Investigator	Ann Arbor	Michigan
United States	Local Investigator	Atlanta	Georgia
United States	Local Investigator	Birmingham	Alabama
United States	Local Investigator	Charlotte	North Carolina
United States	Local Investigator	Chicago	Illinois
United States	Local Investigator	Cleveland	Ohio
United States	Local Investigator	Dallas	Texas
United States	Local Investigator	Dundalk	Maryland
United States	Local Investigator	Fairfax	Virginia
United States	Local Investigator	Farmington	Connecticut
United States	Local Investigator	Honolulu	Hawaii
United States	Local Investigator	Iowa City	Iowa
United States	Local Investigator	Kansas City	Kansas
United States	Local Investigator	La Jolla	California
United States	Local Investigator	Los Angeles	California
United States	Local Investigator	Manhasset	New York
United States	Local Investigator	Miami Beach	Florida
United States	Local Investigator	Nashville	Tennessee
United States	Local Investigator	New York	New York
United States	Local Investigator	Orange	California
United States	Local Investigator	Philadelphia	Pennsylvania
United States	Local Investigator	Pittsburgh	Pennsylvania
United States	Local Investigator	Providence	Rhode Island
United States	Local Investigator	Richmond	Virginia
United States	Local Investigator	Rochester	New York
United States	Local Investigator	Royal Oak	Michigan
United States	Local Investigator	San Francisco	California
United States	Local Investigator	Seattle	Washington
United States	Local Investigator	St. Paul	Minnesota
United States	Local Investigator	Tucson	Arizona
United States	Local Investigator	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm