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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:
ClinicalTrials.gov Identifier:
NCT00096811
First Posted: November 16, 2004
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatitis B Early Access Program
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00096811     History of Changes
Other Study ID Numbers: AI463-900
First Submitted: November 15, 2004
First Posted: November 16, 2004
Last Update Posted: September 21, 2016
Last Verified: September 2016

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