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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Lamivudine Hepatitis B Vaccines Entecavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

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

Study ID Numbers:	AI463-026
Study First Received:	May 10, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00036608
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Entecavir
Digestive System Diseases
Hepatitis, Chronic

Hepatitis B, Chronic
Hepatitis B
Lamivudine
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009