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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00096811
First received: November 15, 2004
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis B
Chronic Disease
 Drug: Entecavir

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:

Drug Information available for: Entecavir
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date: September 2003
Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Entecavir
    Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.
    Other Name: Baraclude
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatitis B Early Access Program
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096811

Locations
Israel
Local Institution
Jerusalem, Israel, 91120
Local Institution
Nazareth, Israel, 16100
Local Institution
Petach Tikva, Israel, 49100
Local Institution
Tel Aviv, Israel, 64239
Local Institution
Zefat, Israel, 13110
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00096811     History of Changes
Other Study ID Numbers: AI463-900
Study First Received: November 15, 2004
Last Updated: May 7, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013