Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cangene Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirti Shetty, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
Not provided
Adult OLT recipients receiving maintenance HBIG therapy were recruited from the inpatient liver transplant service.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
| Blood Glucose Monitoring |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| adult OLT recipients | 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 | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | mg/dL | Pre-dose, immediately following, 60 min and 120 min after injection |
|
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Phase | 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. 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.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring | 0 | 5 | 0 | 5 | ||
| EG001 | Chronic Phase | Study procedures will occur one time at least three (3) months post liver transplant. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG. 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. HepaGam B (Hepatitis B Immune Globulin (HBIG)): Subjects will be gi | 0 | 5 | 0 | 5 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirti Shetty, MD | Johns Hopkins Medicine | 202 660 5555 | kshetty1@jhmi.edu |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C045213 | hepatitis B hyperimmune globulin |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 120 minutes GNS POC minus GS POC |
|
| Predose GNSPOC minus Venous glucose |
|
| PredoseGSPOC minus venous blood glucose |
|
| Post-dose GNS POC minus venous blood glucose |
|
| Post-dose GS POC minus venous blood glucose |
|