Hepatitis B Clinical Trial
Official title:
Evaluation of Blood Glucose Levels for Hepatitis B Immune Globulin (HepaGam B) Administration
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.
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
HBIG, HepaGam B, contains the disaccharide maltose, which can potentially falsely elevate
glucose readings when glucose nonspecific point of care (GNSPOC) testing is used, such as a
glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)-based method. This can result in
inappropriate administration of antidiabetic agents and resultant episodes of clinically
significant hypoglycemia. Glucose specific point of care (GSPOC) testing, such as a glucose
oxidase-based method, however, is not affected by the presence of maltose. The purpose of
this study was to determine if there was a significant difference in glucose readings using
GSPOC and GNSPOC monitoring devices after HBIG administration.
METHODS:
This is a nonrandomized, prospective study evaluating patients receiving maintenance HBIG
therapy over 3 months post liver transplantation. Blood glucose levels in each subject were
analyzed by GSPOC and GNSPOC devices at specific times around HBIG administration.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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