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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT00096811
Other study ID # AI463-900
Secondary ID
Status No longer available
Phase N/A
First received November 15, 2004
Last updated September 20, 2016
Start date September 2003
Est. completion date August 2008

Study information

Verified date September 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Hepatitis B Early Access Program

Study Design

N/A


Intervention

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

Locations

Country Name City State
Israel Local Institution Jerusalem
Israel Local Institution Nazareth
Israel Local Institution Petach Tikva
Israel Local Institution Tel Aviv
Israel Local Institution Zefat

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Israel, 

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