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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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00036608
First received: May 10, 2002
Last updated: April 7, 2011
Last verified: January 2010

May 10, 2002
April 7, 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.
Both
16 Years and older
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