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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hepatitis B; Liver Transplantation	Biological: HepaGam B	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Study Start Date :	February 2008
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; HBV-related liver transplant patients	Biological: HepaGam B; Hepatitis B Immunoglobulin

Outcome Measures

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Primary Outcome Measures :

1. Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ]

Secondary Outcome Measures :

1. Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
Palo Alto, California, United States, 94304
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Massachusetts
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Newark, New Jersey, United States, 07101
United States, New York
New York, New York, United States, 10016
New York, New York, United States, 10029
New York, New York, United States, 10032
United States, Ohio
Cleaveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77030
Canada, Quebec
Montreal, Quebec, Canada, H2X3J4

Sponsors and Collaborators

Cangene Corporation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cangene Corporation
ClinicalTrials.gov Identifier:	NCT00722332 History of Changes
Other Study ID Numbers:	HB-009
First Posted:	July 25, 2008
Last Update Posted:	November 1, 2013
Last Verified:	October 2013

Keywords provided by Cangene Corporation:

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

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis B; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections	RNA Virus Infections; Hepadnaviridae Infections; DNA Virus Infections; Antiviral Agents; Immunoglobulins; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs