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

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.

• Procedure: glucose monitoring before and after HepaGam B administration
  Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.
  Other Names:

  • HepaGam B
  • Hepatitis B Immune Globulin
• Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))
  Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring.

• Active Comparator: Acute phase
  Study procedures will occur one time between 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.
  Interventions:

  • Procedure: glucose monitoring before and after HepaGam B administration
  • Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))
• Active Comparator: chronic phase
  Study procedures will occur one time at least three (3) months post liver transplant. Study procedures to include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
  Interventions:

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

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