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

This study has been completed.

First Received: May 10, 2002 Last Updated: June 27, 2008 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00036608

Purpose

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.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036608

Show 39 Study Locations

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

No publications provided

Study ID Numbers:	AI463-026
Study First Received:	May 10, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00036608 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