DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Georgetown University
ClinicalTrials.gov processed this data on August 20, 2015
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: Completed

Sponsored by: Georgetown University

Official(s) and/or principal investigator(s):
Kirti Shetty, MD, Principal Investigator, Affiliation: Georgetown University

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: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

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

Georgetown University Hospital, Washington, District of Columbia 20007, United States
Additional Information

Starting date: October 2009
Last updated: March 21, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017