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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Georgetown University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cangene Corporation
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00998426
First received: October 7, 2009
Last updated: March 30, 2011
Last verified: June 2010
History of Changes
  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 4

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

Resource links provided by NLM:

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: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acute phase
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.
Other Names:
  • HepaGam B
  • Hepatitis B Immune Globulin
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.
Active Comparator: chronic phase
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.
Other Names:
  • HepaGam B
  • Hepatitis B Immune Globulin
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.

  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: Anna Argyris 202-444-3700

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Anna Argyris     202-444-3700        
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: Kirti Shetty, MD, Georgetown University Medical Center
ClinicalTrials.gov Identifier: NCT00998426     History of Changes
Other Study ID Numbers: 2009-337
Study First Received: October 7, 2009
Last Updated: March 30, 2011
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:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013