NCT00096811

Brief Summary

The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and that have no other available treatment options.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

September 1, 2003

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

4.9 years

First QC Date

November 15, 2004

Last Update Submit

September 20, 2016

Conditions

Hepatitis BChronic Disease

Interventions

EntecavirDRUG

Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.

Also known as: Baraclude

Eligibility Criteria

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

You may qualify if:

  • Hepatitis B Early Access Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Local Institution

Jerusalem, 91120, Israel

Location

Local Institution

Nazareth, 16100, Israel

Location

Local Institution

Petah Tikva, 49100, Israel

Location

Local Institution

Safed, 13110, Israel

Location

Local Institution

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Hepatitis BChronic Disease

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2004

First Posted

November 16, 2004

Study Start

September 1, 2003

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

IL(5)