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

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ClinicalTrials.gov Identifier: NCT00036608
Recruitment Status : Completed
First Posted : May 13, 2002
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : January 2002
Primary Completion Date : February 2005
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Eligibility Criteria

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 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

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): NCT00036608


  Show 39 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00036608     History of Changes
Other Study ID Numbers: AI463-026
First Posted: May 13, 2002    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: January 2010

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Entecavir
Antiviral Agents
Anti-Infective Agents