Clinical trial NCT00035633: A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-06
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Investigator
state: Alabama
city: Tucson
country: United States
facility: Local Investigator
state: Arizona
city: La Jolla
country: United States
facility: Local Investigator
state: California
city: Los Angeles
country: United States
facility: Local Investigator
state: California
city: Orange
country: United States
facility: Local Investigator
state: California
city: Palo Alto
country: United States
facility: Local Investigator
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Torrance
country: United States
facility: Local Investigator
state: California
city: Farmington
country: United States
facility: Local Investigator
state: Connecticut
city: Miami
country: United States
facility: Local Investigator
state: Florida
city: Atlanta
country: United States
facility: Local Investigator
state: Georgia
city: Atlanta
country: United States
facility: Local Investigator
state: Georgia
city: Honolulu
country: United States
facility: Local Investigator
state: Hawaii
city: Chicago
country: United States
facility: Local Investigator
state: Illinois
city: Iowa City
country: United States
facility: Local Investigator
state: Iowa
city: Boston
country: United States
facility: Local Investigator
state: Massachusetts
city: Worcester
country: United States
facility: Local Investigator
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Investigator
state: Michigan
city: Royal Oak
country: United States
facility: Local Investigator
state: Michigan
city: St Paul
country: United States
facility: Local Investigator
state: Minnesota
city: Manhasset
country: United States
facility: Local Investigator
state: New York
city: New York
country: United States
facility: Local Investigator
state: New York
city: New York
country: United States
facility: Local Investigator
state: New York
city: New York
country: United States
facility: Local Investigator
state: New York
city: Rochester
country: United States
facility: Local Investigator
state: New York
city: Charlotte
country: United States
facility: Local Investigator
state: North Carolina
city: Cleveland
country: United States
facility: Local Investigator
state: Ohio
city: Philadelphia
country: United States
facility: Local Investigator
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Investigator
state: Pennsylvania
city: Providence
country: United States
facility: Investigator Meeting
state: Rhode Island
city: Nashville
country: United States
facility: Local Investigator
state: Tennessee
city: Dallas
country: United States
facility: Local Investigator
state: Texas
city: Fairfax
country: United States
facility: Local Investigator
state: Virginia
city: Richmond
country: United States
facility: Local Investigator
state: Virginia
city: Seattle
country: United States
facility: Local Investigator
state: Washington
Study officials:
References:
citation: 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. doi: 10.1056/NEJMoa051285.