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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT00722332
First received: July 23, 2008
Last updated: October 30, 2013
Last verified: October 2013
  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 4

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:


Further study details as provided by Cangene Corporation:

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

Secondary Outcome Measures:
  • Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2008
Study Completion Date: October 2013
Primary Completion Date: October 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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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, 10029
New York, New York, United States, 10032
New York, New York, United States, 10016
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

No publications provided

Responsible Party: Cangene Corporation
ClinicalTrials.gov Identifier: NCT00722332     History of Changes
Other Study ID Numbers: HB-009
Study First Received: July 23, 2008
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

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
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014