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

NCT00998426 | Completed Phase 4 Results

• 1 other identifier: 2009-337
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Hepatitis B

Keywords

hepatitis B immune globulin; HBIG; HepaGam B; orthotopic liver transplant

Outcome Measures

Primary Outcomes (1)

• Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection

  All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).

  Pre-dose, immediately following, 60 min and 120 min after injection

Study Arms (1)

All study participants

EXPERIMENTAL

Study procedures will occur one timebetween 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; Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))

Interventions

glucose monitoring before and after HepaGam B administration 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.

Also known as: HepaGam B, Hepatitis B Immune Globulin

All study participants

HepaGam B (Hepatitis B Immune Globulin (HBIG)) BIOLOGICAL

Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring.

All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Cangene Corporation: collaborator

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Kirti Shetty, MD
• Organization: Johns Hopkins Medicine

kshetty1@jhmi.edu

202 660 5555

Study Officials

• Kirti Shetty, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 28, 2015
• Results First Posted: September 28, 2015

Record last verified: 2015-04

Locations

US (1)