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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B, Liver Transplantation

Intervention / Treatment
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* Biological: HepaGam B


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HBV-related liver transplant patients | Biological: HepaGam B<br>* Hepatitis B Immunoglobulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of HepaGam B in combination with antiviral therapy |  | 15 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy |  | 15 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBIG (Hepatitis B Immune Globulin), Chronic Hepatitis B Recurrence, Liver Transplant