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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00722332

Enrollment

Registered

2008-07-25

Start date

2008-02-29

Completion date

2013-10-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Liver Transplantation

Keywords

HBIG (Hepatitis B Immune Globulin), Chronic Hepatitis B Recurrence, Liver Transplant

Brief summary

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.

Interventions

BIOLOGICALHepaGam B

Hepatitis B Immunoglobulin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Efficacy of HepaGam B in combination with antiviral therapy	15 month follow-up

Secondary

Measure	Time frame
Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy	15 month follow-up

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026