Status:
COMPLETED
Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Cangene Corporation
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
HepaGam B Hepatitis B Immune Globulin (HBIG) solution contains 10% maltose, which could possibly interfere with the measurement of glucose levels when using glucose non-specific tests. The purpose of ...
Detailed Description
BACKGROUND: Hepatitis B Immune Globulin (HBIG) is used post liver transplantation (OLT) in hepatitis B surface antigen-positive recipients to prevent recurrence of hepatitis B. One formulation of HBI...
Eligibility Criteria
Inclusion
- written informed consent
- HBsAG positive candidates for HBV related liver transplant to be placed on HepaGam B therapy for the prevention of HBV recurrence in both the acute phase (immediately post operative) and the long term maintenance phase
- at least 18 years of age
Exclusion
- unable or unwilling to provide written informed consent
- concomitant administration of other maltose containing products such as dietary supplements, dietary aids, IVIG, external peritoneal dialysis solution in both arms
- concomitant administration of corticosteroids in the long term maintenance phase
- pregnancy, as determined by a pregnancy test administered after consent has been signed
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00998426
Start Date
October 1 2009
End Date
December 1 2011
Last Update
September 28 2015
Active Locations (1)
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1
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007