Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

Cangene

Status and phase

Completed

Phase 4

Conditions

Liver Transplantation

Hepatitis B

Treatments

Biological: HepaGam B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00722332

HB-009

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Volunteers

No Healthy Volunteers

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