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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035633
First received: May 4, 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 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 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by Bristol-Myers Squibb:

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

ClinicalTrials.gov Identifier: NCT00035633     History of Changes
Other Study ID Numbers: AI463-022
Study First Received: May 4, 2002
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013