A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen - Tabular View

Tracking Information
First Received Date ^ICMJE	May 4, 2002
Last Updated Date	June 27, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: Entecavir
Study Arms / Comparison Groups
Publications *	Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1001-10.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00035633
Responsible Party
Study ID Numbers ^ICMJE	AI463-022
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	August 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP