Evaluation of HepaGam B™ in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients - Full Text View

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

This study is currently recruiting participants.
Verified by Cangene Corporation, September 2008

Sponsored by:	Cangene Corporation
Information provided by:	Cangene Corporation
ClinicalTrials.gov Identifier:	NCT00722332

Purpose

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	Intervention	Phase
Hepatitis B Liver Transplantation	Biological: HepaGam B	Phase IV

MedlinePlus related topics:

Hepatitis Hepatitis B Liver Transplantation

Drug Information available for:

Hepatitis B Vaccines Immunoglobulins Globulin, Immune Hepatitis B hyperimmune globulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment

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

Further study details as provided by Cangene Corporation:

Primary Outcome Measures:

Pharmacokinetic profile of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental HBV-related liver transplant patients	Biological: HepaGam B Hepatitis B Immunoglobulin

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HBsAg-positive candidates for HBV-related liver transplant
One or more of the following risk factors:

1. HBV DNA positive, 2. HBeAg positive, 3. Evidence of resistance to an antiviral medication
Treatment with antiviral therapy before transplantation as per treating

Exclusion Criteria:

Multi-organ transplantation recipients
Liver re-transplantation except for primary non-function
Presence of a hepatoma (Milan Criteria).
Patients requiring an OLT due to fulminant hepatitis B
OLT patients receiving a liver graft from a donor that is positive for HBsAg
History of IgA 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
Pregnancy or planned pregnancy during the course of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722332

Contacts


Contact: Deepak Jain, MD	416-675-8306	djain@cangene.com

Locations


United States, California
	Stanford University Medical Center	Recruiting
	Palo Alto, California, United States, 94304
	University of Southern California	Recruiting
	Los Angeles, California, United States, 90033

United States, Illinois
	Northwestern Medical Faculty Foundation	Recruiting
	Chicago, Illinois, United States, 60611

United States, Massachusetts
	Lahey Clinic Med Ctr	Recruiting
	Boston, Massachusetts, United States, 01805

United States, New Jersey
	Univ Med and Dentistry of New Jersey	Recruiting
	Newark, New Jersey, United States, 07101

United States, New York
	Mount Sinai Medical Center	Recruiting
	New York, New York, United States, 10029

United States, Ohio
	Cleveland Clinic Foundation	Recruiting
	Cleveland, Ohio, United States, 44195

United States, Pennsylvania
	University of Pittsburgh Med Ctr	Recruiting
	Pittsburgh, Pennsylvania, United States, 15123

United States, Texas
	Baylor University Medical Center	Recruiting
	Dallas, Texas, United States, 75246
	Baylor College of Medicine	Recruiting
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Cangene Corporation

More Information

Responsible Party:	Cangene Corporation ( Deepak Jain, MD Manager, Medical Affairs )
Study ID Numbers:	HB-009
First Received:	July 23, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00722332
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cangene Corporation:

HBIG

Chronic Hepatitis B Recurrence

Liver Transplant

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Hepatitis B, Chronic

Hepatitis B

Hepatitis, Viral, Human

DNA Virus Infections

Recurrence

Immunoglobulins

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 24, 2008