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

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ClinicalTrials.gov Identifier: NCT00035789
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : November 2001
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00035789


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Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 of Results:

ClinicalTrials.gov Identifier: NCT00035789     History of Changes
Other Study ID Numbers: AI463-027
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: January 2010

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