Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Primary Purpose
Hepatitis B, Liver Transplantation
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
HepaGam B
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring HBIG (Hepatitis B Immune Globulin), Chronic Hepatitis B Recurrence, Liver Transplant
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
HBV-related liver transplant patients
Outcomes
Primary Outcome Measures
Efficacy of HepaGam B in combination with antiviral therapy
Secondary Outcome Measures
Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00722332
Brief Title
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Official Title
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cangene Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Liver Transplantation
Keywords
HBIG (Hepatitis B Immune Globulin), Chronic Hepatitis B Recurrence, Liver Transplant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
HBV-related liver transplant patients
Intervention Type
Biological
Intervention Name(s)
HepaGam B
Intervention Description
Hepatitis B Immunoglobulin
Primary Outcome Measure Information:
Title
Efficacy of HepaGam B in combination with antiviral therapy
Time Frame
15 month follow-up
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy
Time Frame
15 month follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Cleaveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X3J4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
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