Evaluation of HepaGam B� in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Information source: Cangene Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B; Liver Transplantation
Intervention: HepaGam B (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Cangene Corporation
Summary
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B
in combination with antiviral therapy for the prevention of hepatitis B virus (HBV)
recurrence following HBV-related orthotopic liver transplant.
Clinical Details
Official title: Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Efficacy of HepaGam B in combination with antiviral therapy
Secondary outcome: Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent
- 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:
- Multi-organ transplantation recipients
- 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
Locations and Contacts
Los Angeles, California 90033, United States
Los Angeles, California 90095, United States
Palo Alto, California 94304, United States
Atlanta, Georgia 30322, United States
Chicago, Illinois 60611, United States
Burlington, Massachusetts 01805, United States
Minneapolis, Minnesota 55455, United States
Newark, New Jersey 07101, United States
New York, New York 10032, United States
New York, New York 10029, United States
New York, New York 10016, United States
Cleaveland, Ohio 44195, United States
Pittsburgh, Pennsylvania 15213, United States
Montreal, Quebec H2X3J4, Canada
Dallas, Texas 75246, United States
Houston, Texas 77030, United States
Additional Information
Starting date: February 2008
Last updated: October 30, 2013
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