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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
  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
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: NCT00035633

  Hide Study Locations
Locations
United States, Alabama
Local Investigator
Birmingham, Alabama, United States, 35294
United States, Arizona
Local Investigator
Tucson, Arizona, United States, 85724
United States, California
Local Investigator
La Jolla, California, United States, 92037
Local Investigator
Los Angeles, California, United States, 90048
Local Investigator
Orange, California, United States, 92868
Local Investigator
Palo Alto, California, United States, 94304
Local Institution
San Francisco, California, United States, 94115
Local Investigator
Torrance, California, United States, 90505
United States, Connecticut
Local Investigator
Farmington, Connecticut, United States, 06030
United States, Florida
Local Investigator
Miami, Florida, United States, 33136
United States, Georgia
Local Investigator
Atlanta, Georgia, United States, 30322
Local Investigator
Atlanta, Georgia, United States, 30309
United States, Hawaii
Local Investigator
Honolulu, Hawaii, United States, 96820
United States, Illinois
Local Investigator
Chicago, Illinois, United States, 60622
United States, Iowa
Local Investigator
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Local Investigator
Boston, Massachusetts, United States, 02111
Local Investigator
Worcester, Massachusetts, United States, 01655
United States, Michigan
Local Investigator
Ann Arbor, Michigan, United States, 48109
Local Investigator
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Local Investigator
St Paul, Minnesota, United States, 55114
United States, New York
Local Investigator
Manhasset, New York, United States, 11030
Local Investigator
New York, New York, United States, 10029
Local Investigator
New York, New York, United States, 10032
Local Investigator
New York, New York, United States, 10003
Local Investigator
Rochester, New York, United States, 14642
United States, North Carolina
Local Investigator
Charlotte, North Carolina, United States, 28203
United States, Ohio
Local Investigator
Cleveland, Ohio, United States, 44125
United States, Pennsylvania
Local Investigator
Philadelphia, Pennsylvania, United States, 19104
Local Investigator
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Investigator Meeting
Providence, Rhode Island, United States, 02908
United States, Tennessee
Local Investigator
Nashville, Tennessee, United States, 37211
United States, Texas
Local Investigator
Dallas, Texas, United States, 75235
United States, Virginia
Local Investigator
Fairfax, Virginia, United States, 22031
Local Investigator
Richmond, Virginia, United States, 23249
United States, Washington
Local Investigator
Seattle, Washington, United States, 98195
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 B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Entecavir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014