Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
NCT ID: NCT00722332
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
9 participants
INTERVENTIONAL
2008-02-29
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
HBV-related liver transplant patients
HepaGam B
Hepatitis B Immunoglobulin
Interventions
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HepaGam B
Hepatitis B Immunoglobulin
Eligibility Criteria
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Inclusion Criteria
* HBsAg-positive candidates for HBV-related liver transplant
* Treatment with antiviral therapy before transplantation as per treating physician's recommendation. (NOTE: It is expected that most patients will receive Lamivudine or Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)
Exclusion Criteria
* Liver re-transplantation except for primary non-function
* Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at baseline visit (CT scan, MRI).
* Patients requiring an OLT (Orthotopic Liver Transplant)due to fulminant hepatitis B
* OLT patients receiving a liver graft from a donor that is positive for HBsAg
* Patients using interferon pre-transplant (as interferon cannot be used post-transplant)
* History of IgA (immunoglobulin A) deficiency
* History of hypersensitivity to blood products.
* HIV or HCV positive
* Use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
* Pregnancy or planned pregnancy during the course of the study
ALL
No
Sponsors
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Cangene Corporation
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Burlington, Massachusetts, United States
Minneapolis, Minnesota, United States
Newark, New Jersey, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Montreal, Quebec, Canada
Countries
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Other Identifiers
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HB-009
Identifier Type: -
Identifier Source: org_study_id