Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients
Information source: Georgetown University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: glucose monitoring before and after HepaGam B administration (Procedure); HepaGam B (Hepatitis B Immune Globulin (HBIG)) (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Georgetown University Official(s) and/or principal investigator(s):
Kirti Shetty, MD, Principal Investigator, Affiliation: Georgetown University
Overall contact:
Shea Mertens, Phone: 202-444-1769, Email: shea.mertens@gunet.georgetown.edu
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.
Clinical Details
Official title: Evaluation of Blood Glucose Levels for Hepatitis B Immune Globulin (HepaGam B) Administration
Study design: Supportive Care, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: change in blood glucose levels prior to HBIG injection and after HBIG injection to determine if there are falsely elevated blood glucose levels after the injection
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Shea Mertens, Phone: 202-444-1769, Email: shea.mertens@gunet.georgetown.edu
Georgetown University Hospital, Washington, District of Columbia 20007, United States; Recruiting
Shea Mertens, B.S., M.A., Phone: 202-444-1769, Email: shea.mertens@gunet.georgetown.edu
Kirti Shetty, MD, Principal Investigator
Additional Information
Starting date: October 2009
Ending date: July 2010
Last updated: October 19, 2009
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