Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00722332
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00722332
Study Brief:
Protocol Section:
NCT00722332