Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Completed · Phase 4
Conditions studied: Hepatitis B, Liver Transplantation
In brief
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.
Key facts
- Study ID
- NCT00722332
- Run by
- Cangene Corporation
- People needed
- 9
- Starts
- 2008-02-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2013-11-01
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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
Where it is running
- Study site — Los Angeles, California, United States
- Study site — Los Angeles, California, United States
- Study site — Palo Alto, California, United States
- Study site — Atlanta, Georgia, United States
- Study site — Chicago, Illinois, United States
- Study site — Burlington, Massachusetts, United States
- Study site — Minneapolis, Minnesota, United States
- Study site — Newark, New Jersey, United States
- Study site — New York, New York, United States
- Study site — New York, New York, United States
- Study site — New York, New York, United States
- Study site — Cleveland, Ohio, United States
- Study site — Pittsburgh, Pennsylvania, United States
- Study site — Dallas, Texas, United States
- Study site — Houston, Texas, United States
- Study site — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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