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

First Received: July 23, 2008 Last Updated: September 8, 2008 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B Liver Transplantation

Drug Information available for: Hepatitis B hyperimmune globulin Hepatitis B Vaccines

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Cangene Corporation:

HBIG
Chronic Hepatitis B Recurrence
Liver Transplant

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
Anti-Infective Agents
Liver Diseases
Digestive System Diseases
Therapeutic Uses

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010