Clinical trial NCT00035789: A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative 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 and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.


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;
* HBeAg negative, anti-HBeAb 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;
* 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: San Francisco
country: United States
facility: Local Investigator
state: California
city: Farmington
country: United States
facility: Local Investigator
state: Connecticut
city: Miami Beach
country: United States
facility: Local Investigator
state: Florida
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: Kansas City
country: United States
facility: Local Investigator
state: Kansas
city: Dundalk
country: United States
facility: Local Investigator
state: Maryland
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: 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: Local Investigator
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: Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, Goodman Z, DeHertogh D, Wilber R, Zink RC, Cross A, Colonno R, Fernandes L; BEHoLD AI463027 Study Group. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1011-20. doi: 10.1056/NEJMoa051287.