A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00036608
First received: May 10, 2002
Last updated: April 7, 2011
Last verified: January 2010
  Purpose

The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.


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: January 2002
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 HBeAg-positive chronic hepatitis B infection;
  • Incomplete response to current lamivudine therapy;
  • HBeAg-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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036608

  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, 90095
Local Investigator
Los Angeles, California, United States, 90048
Local Investigator
Orange, California, United States, 92868
Local Investigator
San Diego, California, United States, 92115
Local Investigator
San Francisco, California, United States, 94115
United States, Connecticut
Local Investigator
Farmington, Connecticut, United States, 06030
United States, Florida
Local Investigator
Miami, Florida, United States, 33136
Local Investigator
Miami Beach, Florida, United States, 33140
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
Local Investigator
Chicago, Illinois, United States, 60612
United States, Iowa
Local Investigator
Iowa City, Iowa, United States, 52242
United States, Louisiana
Local Investigator
New Orleans, Louisiana, United States, 70112
United States, Maryland
Local Investigator
Dundalk, Maryland, United States, 21205
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
Local Investigator
Durham, North Carolina, United States, 27710
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
Local Investigator
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
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00036608     History of Changes
Other Study ID Numbers: AI463-026
Study First Received: May 10, 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 17, 2014