A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
ClinicalTrials.gov ID
NCT00036608
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Last Update Posted
Apr 14, 2011Estimated
Start Date
Jan 2002
Primary Completion Date
Feb 2005Actual
Completion Date
Feb 2005Actual
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.
Chronic Hepatitis B
Entecavir
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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.