View Clinical Trial (Medical Research Study)
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
| City: |
|
New York |
| State: |
|
New York |
| Zip Code: |
|
10032 |
| Conditions: |
|
Hepatitis B - Liver Transplantation |
| Purpose: |
|
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.
|
| Study Summary: |
|
|
| 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 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 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
|
| NCT ID: |
|
NCT00722332 |
| Primary Contact: |
|
Christine Hall, PhD
Phone: (204) 275-4248
Email: chall@cangene.com
|
| Backup Contact: |
|
Email: puppin@cangene.com
Priya Uppin, MSc
Phone: (204) 275 4531
|
| Location Contact: |
|
New York, New York 10032
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|