Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 5/27/2013 |
Start Date: | February 2008 |
End Date: | January 2014 |
Contact: | Christine Hall, PhD |
Email: | chall@cangene.com |
Phone: | (204) 275-4248 |
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.
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 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 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
We found this trial at
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