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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00722332
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation

Tracking Information
First Submitted Date  ICMJE July 23, 2008
First Posted Date  ICMJE July 25, 2008
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2008)
Pharmacokinetic profile of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2008)
Safety and Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Official Title  ICMJE Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatitis B
  • Liver Transplantation
Intervention  ICMJE Biological: HepaGam B
Hepatitis B Immunoglobulin
Study Arms  ICMJE Experimental: 1
HBV-related liver transplant patients
Intervention: Biological: HepaGam B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2008)
30
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00722332
Other Study ID Numbers  ICMJE HB-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cangene Corporation
Study Sponsor  ICMJE Cangene Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cangene Corporation
Verification Date October 2013

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