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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00035789

First received: May 5, 2002

Last updated: April 7, 2011

Last verified: January 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Entecavir	Phase 3


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Entecavir

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:


Study Start Date:	November 2001
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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;
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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035789

Show 31 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:

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 Mar 9;354(10):1011-20. Erratum in: N Engl J Med. 2006 Apr 27;354(17):1863.


ClinicalTrials.gov Identifier:	NCT00035789 History of Changes
Other Study ID Numbers:	AI463-027
Study First Received:	May 5, 2002
Last Updated:	April 7, 2011

Additional relevant MeSH terms:


Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases	Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Entecavir Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017

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