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A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative 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
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 5, 2002
Last Updated
April 7, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00035789
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 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 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.

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; 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)
Facility Information:
Facility Name
Local Investigator
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Local Investigator
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Local Investigator
City
La Jolla
State/Province
California
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
Country
United States
Facility Name
Local Investigator
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Investigator
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
Local Investigator
City
Miami Beach
State/Province
Florida
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
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
Country
United States
Facility Name
Local Investigator
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Local Investigator
City
Dundalk
State/Province
Maryland
Country
United States
Facility Name
Local Investigator
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Local Investigator
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Local Investigator
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Local Investigator
City
St. Paul
State/Province
Minnesota
Country
United States
Facility Name
Local Investigator
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Local Investigator
City
New York
State/Province
New York
Country
United States
Facility Name
Local Investigator
City
Rochester
State/Province
New York
Country
United States
Facility Name
Local Investigator
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Local Investigator
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Investigator
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Investigator
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Local Investigator
City
Providence
State/Province
Rhode Island
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
Country
United States
Facility Name
Local Investigator
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Local Investigator
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Local Investigator
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16525138
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. Erratum In: N Engl J Med. 2006 Apr 27;354(17):1863.
Results Reference
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A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

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