Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cangene Corporation
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.)
You may not be if
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
Clareo Health | Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
