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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00035633
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : April 14, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Entecavir Phase 3

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : December 2001
Primary Completion Date : February 2005
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00035633

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Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
Publications of Results: Identifier: NCT00035633     History of Changes
Other Study ID Numbers: AI463-022
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: January 2010

Additional relevant MeSH terms:
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
Antiviral Agents
Anti-Infective Agents