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Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program

Primary Purpose

Hepatitis B, Chronic Disease

Status
No longer available
Phase
Locations
Israel
Study Type
Expanded Access
Intervention
Entecavir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Hepatitis B

Eligibility Criteria

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

Inclusion Criteria: Hepatitis B Early Access Program

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 15, 2004
Last Updated
September 20, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00096811
Brief Title
Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program
Official Title
A Treatment Use Protocol of Entecavir in Subjects With Chronic Hepatitis B Infection Who Have Failed or Who Are Intolerant of Available Therapies
Study Type
Expanded Access

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
No longer available
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic Disease

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude
Intervention Description
Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hepatitis B Early Access Program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Local Institution
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Zefat
ZIP/Postal Code
13110
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program

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