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View Clinical Trial (Medical Research Study)


Evaluation of Blood Glucose Levels for Hepatitis B Immune Globulin (HepaGam B) Administration

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City:   Washington
State:   District of Columbia
Zip Code:   20007
Conditions:   Hepatitis B
Purpose:   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 this study is to determine whether use of HepaGam B HBIG shows an increase in glucose levels in the body using non-specific glucose monitoring, as well as specific glucose monitoring. The sponsor believes that this medication will not cause a significant increase in glucose levels in the body when measured by glucose non-specific tests.
Study Summary:  
Criteria:   Inclusion Criteria: - 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 Criteria: - 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
NCT ID:   NCT00998426
Primary Contact:   Principal Investigator
Kirti Shetty, MD
Georgetown University

Anna Argyris
Phone: 202-444-3700
Backup Contact:   N/A
Location Contact:   Washington, District of Columbia 20007
United States

Anna Argyris
Phone: 202-444-3700

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   May 25, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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