A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036608
• Other study ID #: AI463-026
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2002
• Last updated: April 7, 2011
• Start date: January 2002
• Est. completion date: February 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 switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2005
• Est. primary completion date: February 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 HBeAg-positive chronic hepatitis B infection;

• Incomplete response to current lamivudine therapy;

• HBeAg-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.

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	Atlanta	Georgia
United States	Local Investigator	Birmingham	Alabama
United States	Local Investigator	Boston	Massachusetts
United States	Local Investigator	Charlotte	North Carolina
United States	Local Investigator	Chicago	Illinois
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	Durham	North Carolina
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	La Jolla	California
United States	Local Investigator	Los Angeles	California
United States	Local Investigator	Los Angeles	California
United States	Local Investigator	Manhasset	New York
United States	Local Investigator	Miami	Florida
United States	Local Investigator	Miami Beach	Florida
United States	Local Investigator	Nashville	Tennessee
United States	Local Investigator	New Orleans	Louisiana
United States	Local Investigator	New York	New York
United States	Local Investigator	New York	New York
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 Diego	California
United States	Local Investigator	San Francisco	California
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, 

External Links

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