View Clinical Trial (Medical Research Study)
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30322 |
| Conditions: |
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Hepatitis B - Liver Transplantation |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00722332 |
| Primary Contact: |
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Christine Hall, PhD
Phone: (204) 275-4248
Email: chall@cangene.com
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| Backup Contact: |
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Email: puppin@cangene.com
Priya Uppin, MSc
Phone: (204) 275 4531
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| Location Contact: |
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Atlanta, Georgia 30322
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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