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

This study is currently recruiting participants.

Verified May 2011 by Cangene Corporation

First Received on July 23, 2008. Last Updated on October 25, 2011 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:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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 A Hepatitis B Liver Transplantation

Drug Information available for: Recombinant hepatitis B vaccine Hepatitis B hyperimmune globulin Hepatitis B Vaccines Hepatitis A 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: 15 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	31
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

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

Eligibility

Genders Eligible for Study:	Both
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 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 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

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

Contacts

Contact: Jodi Smith, PhD	(204) 275-4444	jsmith@cangene.com
Contact: Priya Uppin, MSc	(204) 275 4531	puppin@cangene.com

Locations

United States, California
	Recruiting
Los Angeles, California, United States, 90033
	Recruiting
Los Angeles, California, United States, 90095
	Recruiting
Palo Alto, California, United States, 94304
United States, New Jersey
	Recruiting
Newark, New Jersey, United States, 07101
United States, New York
	Recruiting
New York, New York, United States, 10029
	Recruiting
New York, New York, United States, 10032
United States, Pennsylvania
	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
	Recruiting
Houston, Texas, United States, 77030
Canada, Quebec
	Recruiting
Montreal, Quebec, Canada, H2X3J4

Sponsors and Collaborators

Cangene Corporation

More Information

No publications provided

Responsible Party:	Christine Hall, Ph.D., Director, Clinical Research, Cangene Corporation
ClinicalTrials.gov Identifier:	NCT00722332 History of Changes
Other Study ID Numbers:	HB-009
Study First Received:	July 23, 2008
Last Updated:	October 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cangene Corporation:

HBIG
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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012