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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722332
• Other study ID #: HB-009
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2008
• Last updated: October 30, 2013
• Start date: February 2008
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Cangene Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Transplantation

Intervention

Biological:
• HepaGam B
Hepatitis B Immunoglobulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cangene Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of HepaGam B in combination with antiviral therapy		15 month follow-up	No
Secondary	Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy		15 month follow-up	No