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
  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:


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:
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 April 16, 2014