Hepatitis B
Conditions
Keywords
hepatitis B immune globulin, HBIG, HepaGam B, orthotopic liver transplant
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.
Detailed description
BACKGROUND: Hepatitis B Immune Globulin (HBIG) is used post liver transplantation (OLT) in hepatitis B surface antigen-positive recipients to prevent recurrence of hepatitis B. One formulation of HBIG, HepaGam B, contains the disaccharide maltose, which can potentially falsely elevate glucose readings when glucose nonspecific point of care (GNSPOC) testing is used, such as a glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)-based method. This can result in inappropriate administration of antidiabetic agents and resultant episodes of clinically significant hypoglycemia. Glucose specific point of care (GSPOC) testing, such as a glucose oxidase-based method, however, is not affected by the presence of maltose. The purpose of this study was to determine if there was a significant difference in glucose readings using GSPOC and GNSPOC monitoring devices after HBIG administration. METHODS: This is a nonrandomized, prospective study evaluating patients receiving maintenance HBIG therapy over 3 months post liver transplantation. Blood glucose levels in each subject were analyzed by GSPOC and GNSPOC devices at specific times around HBIG administration.
Interventions
PROCEDUREglucose 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.
BIOLOGICALHepaGam 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
Cangene Corporation
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | Pre-dose, immediately following, 60 min and 120 min after 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). |
Countries
United States
Participant flow
Recruitment details
Adult OLT recipients receiving maintenance HBIG therapy were recruited from the inpatient liver transplant service.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous 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.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| adult OLT recipients | 5 participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
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).
Time frame: Pre-dose, immediately following, 60 min and 120 min after injection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | Pre Dose: GNS POC minus GS POC | -3.2 mg/dL | Standard Deviation 8.2 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | Post Dose GNS POC minus GS POC | 6.0 mg/dL | Standard Deviation 13.5 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | 60 minutes GNS POC minus GS POC | 56.6 mg/dL | Standard Deviation 125.1 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | 120 minutes GNS POC minus GS POC | -2.6 mg/dL | Standard Deviation 10.1 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | Predose GNSPOC minus Venous glucose | 7.4 mg/dL | Standard Deviation 3.5 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | PredoseGSPOC minus venous blood glucose | 10.6 mg/dL | Standard Deviation 6 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | Post-dose GNS POC minus venous blood glucose | 17 mg/dL | Standard Deviation 12.5 |
| All Study Participants | Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection | Post-dose GS POC minus venous blood glucose | 11 mg/dL | Standard Deviation 25.7 |
Comparison: A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.p-value: 0.59Random intercept model