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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00036608
First Posted: May 13, 2002
Last Update Posted: April 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
May 10, 2002
May 13, 2002
April 14, 2011
January 2002
February 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00036608 on ClinicalTrials.gov Archive Site
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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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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.
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Interventional
Phase 3
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: Entecavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2005
February 2005   (Final data collection date for primary outcome measure)
  • 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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00036608
AI463-026
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Bristol-Myers Squibb
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Bristol-Myers Squibb
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP