Clinical trial NCT00722332: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Liver Transplantation
Keywords: HBIG (Hepatitis B Immune Globulin)
Chronic Hepatitis B Recurrence
Liver Transplant
Lead sponsor: Cangene Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Efficacy of HepaGam B in combination with antiviral therapy
timeFrame: 15 month follow-up
Secondary outcomes:
measure: Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy
timeFrame: 15 month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Burlington
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cleaveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Montreal
country: Canada
state: Quebec
Study officials:
References: