Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients

Phase 4

Completed

Interventions: Procedure: glucose monitoring before and after HepaGam B administration
Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))

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 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.

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
All study participants	glucose monitoring before and after HepaGam B administration	Study procedures will occur one timebetween post-op day 1 and post-op day 7. Study procedures to include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
All study participants	HepaGam B (Hepatitis B Immune Globulin (HBIG))	Study procedures will occur one timebetween post-op day 1 and post-op day 7. Study procedures to include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.

Primary Outcome Measures

Name	Time	Method
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection	Pre-dose, immediately following, 60 min and 120 min after injection	All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).

Secondary Outcome Measures