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

This study has been completed.

First Received: May 4, 2002 Last Updated: June 27, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035633

Purpose

The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.

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 chronic hepatitis B infection;
Documentation of positive Hepatitis B e antigen (HBeAg) status.;
The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
The 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035633

Show 35 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

Publications:

Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1001-10.

Study ID Numbers:	AI463-022
Study First Received:	May 4, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00035633 History of Changes
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
Antiviral Agents

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 July 02, 2009