TerminatedInterventionalPhase 3Updated Nov 23, 2010
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen | NCT00035633 | Trialant
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
ClinicalTrials.gov ID
NCT00035633
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Last Update Posted
Apr 14, 2011Estimated
Start Date
Dec 2001
Primary Completion Date
Feb 2005Actual
Completion Date
Feb 2005Actual
Brief Summary
The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.
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 chronic hepatitis B infection;
Documentation of positive Hepatitis B e antigen (HBeAg) status.;
The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
The absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)