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

Completed · Phase 4

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT00998426

Run by

Georgetown University

People needed

5

Starts

2009-10-01

Expected to finish

2011-12-01

Last updated by the study team

2015-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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