A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Entecavir

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Local Investigator
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Local Investigator
  • California
    • La Jolla, California, United States, 92037
      • Local Investigator
    • Los Angeles, California, United States, 90048
      • Local Investigator
    • Orange, California, United States, 92868
      • Local Investigator
    • Palo Alto, California, United States, 94304
      • Local Investigator
    • San Francisco, California, United States, 94115
      • Local Institution
    • Torrance, California, United States, 90505
      • Local Investigator
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Local Investigator
  • Florida
    • Miami, Florida, United States, 33136
      • Local Investigator
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Local Investigator
    • Atlanta, Georgia, United States, 30322
      • Local Investigator
  • Hawaii
    • Honolulu, Hawaii, United States, 96820
      • Local Investigator
  • Illinois
    • Chicago, Illinois, United States, 60622
      • Local Investigator
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Local Investigator
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Local Investigator
    • Worcester, Massachusetts, United States, 01655
      • Local Investigator
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Local Investigator
    • Royal Oak, Michigan, United States, 48073
      • Local Investigator
  • Minnesota
    • St Paul, Minnesota, United States, 55114
      • Local Investigator
  • New York
    • Manhasset, New York, United States, 11030
      • Local Investigator
    • New York, New York, United States, 10003
      • Local Investigator
    • New York, New York, United States, 10029
      • Local Investigator
    • New York, New York, United States, 10032
      • Local Investigator
    • Rochester, New York, United States, 14642
      • Local Investigator
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Local Investigator
  • Ohio
    • Cleveland, Ohio, United States, 44125
      • Local Investigator
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Local Investigator
    • Pittsburgh, Pennsylvania, United States, 15213
      • Local Investigator
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Investigator Meeting
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Local Investigator
  • Texas
    • Dallas, Texas, United States, 75235
      • Local Investigator
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Local Investigator
    • Richmond, Virginia, United States, 23249
      • Local Investigator
  • Washington
    • Seattle, Washington, United States, 98195
      • Local Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): February 1, 2005
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: May 4, 2002
• First Submitted That Met QC Criteria: May 5, 2002
• First Posted (Estimate): May 6, 2002

Study Record Updates

• Last Update Posted (Estimate): April 14, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: AI463-022