NCT00036608

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2002

Typical duration for phase_3

Geographic Reach
1 country

39 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

January 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 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

3.1 years

First QC Date

May 10, 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 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.

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

Sponsors & Collaborators

Study Sites (39)

Local Investigator

Birmingham, Alabama, 35294, United States

Location

Local Investigator

Tucson, Arizona, 85724, United States

Location

Local Investigator

La Jolla, California, 92037, United States

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Local Investigator

Los Angeles, California, 90048, United States

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Local Investigator

Los Angeles, California, 90095, United States

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Local Investigator

Orange, California, 92868, United States

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Local Investigator

San Diego, California, 92115, United States

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Local Investigator

San Francisco, California, 94115, United States

Location

Local Investigator

Farmington, Connecticut, 06030, United States

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Local Investigator

Miami, Florida, 33136, United States

Location

Local Investigator

Miami Beach, Florida, 33140, United States

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Local Investigator

Atlanta, Georgia, 30309, United States

Location

Local Investigator

Atlanta, Georgia, 30322, United States

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Local Investigator

Honolulu, Hawaii, 96820, United States

Location

Local Investigator

Chicago, Illinois, 60612, United States

Location

Local Investigator

Chicago, Illinois, 60622, United States

Location

Local Investigator

Iowa City, Iowa, 52242, United States

Location

Local Investigator

New Orleans, Louisiana, 70112, United States

Location

Local Investigator

Dundalk, Maryland, 21205, 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

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Local Investigator

Durham, North Carolina, 27710, United States

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Local Investigator

Cleveland, Ohio, 44125, United States

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Local Investigator

Philadelphia, Pennsylvania, 19104, United States

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Local Investigator

Pittsburgh, Pennsylvania, 15213, United States

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Local Investigator

Providence, Rhode Island, 02908, United States

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Local Investigator

Nashville, Tennessee, 37211, United States

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Local investigator

Dallas, Texas, 75235, United States

Location

Local Investigator

Fairfax, Virginia, 22031, United States

Location

Local Investigator

Richmond, Virginia, 23249, United States

Location

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 10, 2002

First Posted

May 13, 2002

Study Start

January 1, 2002

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

April 14, 2011

Record last verified: 2010-01

Locations

US(39)