Clinical trial NCT00036608: A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-13
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 switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.


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.

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: Los Angeles
country: United States
facility: Local Investigator
state: California
city: Orange
country: United States
facility: Local Investigator
state: California
city: San Diego
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: 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: Chicago
country: United States
facility: Local Investigator
state: Illinois
city: Iowa City
country: United States
facility: Local Investigator
state: Iowa
city: New Orleans
country: United States
facility: Local Investigator
state: Louisiana
city: Dundalk
country: United States
facility: Local Investigator
state: Maryland
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: Durham
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
Study officials:
References: