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

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

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

Inclusion Criteria:

  • Hepatitis B Early Access Program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096811

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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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

ClinicalTrials.gov processed this record on May 04, 2016