Phase 4 N=5 Supportive Care

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

Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT00998426 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcome: Primary: Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection — -3.2; 6.0; 56.6; -2.6 mg/dL — p=0.59

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: glucose monitoring before and after HepaGam B administration (Procedure); HepaGam B (Hepatitis B Immune Globulin (HBIG)) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Georgetown University
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection	-3.2; 6.0; 56.6; -2.6; 7.4; 10.6	0.59

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00998426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.