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

NCT00998426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-09-28

Study results available
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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.

Conditions

Interventions

PROCEDURE

glucose monitoring before and after HepaGam B administration

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.

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.

Sponsors & Collaborators

  • Cangene Corporation

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Kirti Shetty, MD · Georgetown University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00998426 on ClinicalTrials.gov