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

Sponsor:	Georgetown University
Collaborator:	Cangene Corporation
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00998426

Purpose

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.

Condition	Intervention	Phase
Hepatitis B	Procedure: glucose monitoring before and after HepaGam B administration Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Evaluation of Blood Glucose Levels for Hepatitis B Immune Globulin (HepaGam B) Administration

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B Liver Transplantation

Drug Information available for: Dextrose Immunoglobulins Hepatitis B hyperimmune globulin Hepatitis B Vaccines Globulin, Immune

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

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 [ Time Frame: immediately pre-injection to 2 hours after injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	October 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Acute phase: Active Comparator 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.	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. Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))
chronic phase: Active Comparator 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.	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. Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))

Arms

Assigned Interventions

Acute phase: Active Comparator

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.

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.

Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))

chronic phase: Active Comparator

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.

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.

Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998426

Contacts

Contact: Shea Mertens

202-444-1769

shea.mertens@gunet.georgetown.edu

Locations

United States, District of Columbia
Georgetown University Hospital	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Shea Mertens, B.S., M.A. 202-444-1769 shea.mertens@gunet.georgetown.edu
Principal Investigator: Kirti Shetty, MD

Sponsors and Collaborators

Georgetown University

Cangene Corporation

Investigators

Principal Investigator:

Kirti Shetty, MD

Georgetown University

More Information

No publications provided

Responsible Party:	Georgetown University Medical Center ( Kirti Shetty, MD )
Study ID Numbers:	2009-337
Study First Received:	October 7, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00998426 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

hepatitis B immune globulin
HBIG
HepaGam B
orthotopic liver transplant

Additional relevant MeSH terms:

Liver Diseases
Immunologic Factors
Physiological Effects of Drugs
Hepatitis, Viral, Human
Hepadnaviridae Infections
Pharmacologic Actions
Hepatitis

Virus Diseases
Antibodies
Digestive System Diseases
Hepatitis B
DNA Virus Infections
Immunoglobulins

ClinicalTrials.gov processed this record on February 08, 2010