Back to resultsA Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
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)
Sites / Locations
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- Investigator Meeting
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035633
Brief Title
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
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Entecavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
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)
Facility Information:
Facility Name
Local Investigator
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Local Investigator
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Local Investigator
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Local Investigator
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Investigator
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Investigator
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local Investigator
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Local Investigator
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Local Investigator
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Investigator
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Local Investigator
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Investigator
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96820
Country
United States
Facility Name
Local Investigator
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
Local Investigator
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Investigator
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Local Investigator
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Local Investigator
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Investigator
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Local Investigator
City
St Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Local Investigator
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Local Investigator
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Local Investigator
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Investigator
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Local Investigator
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Local Investigator
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Local Investigator
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Local Investigator
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Investigator
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Investigator Meeting
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Local Investigator
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Local Investigator
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Local Investigator
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Investigator
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Local Investigator
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16525137
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.
Results Reference
result
Learn more about this trial
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
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