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

July 23, 2008
October 30, 2013
February 2008
October 2013   (final data collection date for primary outcome measure)
Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
Pharmacokinetic profile of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00722332 on ClinicalTrials.gov Archive Site
Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
Safety and Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hepatitis B
  • Liver Transplantation
Biological: HepaGam B
Hepatitis B Immunoglobulin
Other Name: HepaGam B
Experimental: 1
HBV-related liver transplant patients
Intervention: Biological: HepaGam B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00722332
HB-009
No
Cangene Corporation
Cangene Corporation
Not Provided
Not Provided
Cangene Corporation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP