NCT00035633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2001

Typical duration for phase_3

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

April 14, 2011

Status Verified

January 1, 2010

Enrollment Period

3.2 years

First QC Date

May 4, 2002

Last Update Submit

April 7, 2011

Conditions

Chronic Hepatitis B

Interventions

EntecavirDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (35)

Local Investigator

Birmingham, Alabama, 35294, United States

Location

Local Investigator

Tucson, Arizona, 85724, United States

Location

Local Investigator

La Jolla, California, 92037, United States

Location

Local Investigator

Los Angeles, California, 90048, United States

Location

Local Investigator

Orange, California, 92868, United States

Location

Local Investigator

Palo Alto, California, 94304, United States

Location

Local Institution

San Francisco, California, 94115, United States

Location

Local Investigator

Torrance, California, 90505, United States

Location

Local Investigator

Farmington, Connecticut, 06030, United States

Location

Local Investigator

Miami, Florida, 33136, United States

Location

Local Investigator

Atlanta, Georgia, 30309, United States

Location

Local Investigator

Atlanta, Georgia, 30322, United States

Location

Local Investigator

Honolulu, Hawaii, 96820, United States

Location

Local Investigator

Chicago, Illinois, 60622, United States

Location

Local Investigator

Iowa City, Iowa, 52242, United States

Location

Local Investigator

Boston, Massachusetts, 02111, United States

Location

Local Investigator

Worcester, Massachusetts, 01655, United States

Location

Local Investigator

Ann Arbor, Michigan, 48109, United States

Location

Local Investigator

Royal Oak, Michigan, 48073, United States

Location

Local Investigator

Saint Paul, Minnesota, 55114, United States

Location

Local Investigator

Manhasset, New York, 11030, United States

Location

Local Investigator

New York, New York, 10003, United States

Location

Local Investigator

New York, New York, 10029, United States

Location

Local Investigator

New York, New York, 10032, United States

Location

Local Investigator

Rochester, New York, 14642, United States

Location

Local Investigator

Charlotte, North Carolina, 28203, United States

Location

Local Investigator

Cleveland, Ohio, 44125, United States

Location

Local Investigator

Philadelphia, Pennsylvania, 19104, United States

Location

Local Investigator

Pittsburgh, Pennsylvania, 15213, United States

Location

Investigator Meeting

Providence, Rhode Island, 02908, United States

Location

Local Investigator

Nashville, Tennessee, 37211, United States

Location

Local Investigator

Dallas, Texas, 75235, United States

Location

Local Investigator

Fairfax, Virginia, 22031, United States

Location

Local Investigator

Richmond, Virginia, 23249, United States

Location

Local Investigator

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 16525137RESULT

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 4, 2002

First Posted

May 6, 2002

Study Start

December 1, 2001

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

April 14, 2011

Record last verified: 2010-01

Locations

US(35)