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

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.
 
ClinicalTrials.gov Identifier: NCT00096811
Expanded Access Status : No longer available
First Posted : November 16, 2004
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment
Hepatitis B Chronic Disease Drug: Entecavir

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Study Type : 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
Study Start Date : September 2003
Estimated Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir


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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Hepatitis B Early Access Program

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
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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00096811    
Other Study ID Numbers: AI463-900
First Posted: November 16, 2004    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Chronic Disease
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Disease Attributes
Pathologic Processes
Entecavir
Antiviral Agents
Anti-Infective Agents