View Clinical Trial (Medical Research Study)
Evaluation of Blood Glucose Levels for Hepatitis B Immune Globulin (HepaGam B) Administration
| City: |
|
Washington |
| State: |
|
District of Columbia |
| Zip Code: |
|
20007 |
| Conditions: |
|
Hepatitis B |
| 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.
|
| Study Summary: |
|
|
| 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
|
| NCT ID: |
|
NCT00998426 |
| Primary Contact: |
|
Principal Investigator Kirti Shetty, MD Georgetown University
Anna Argyris Phone: 202-444-3700
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Washington, District of Columbia 20007 United States
Anna Argyris Phone: 202-444-3700
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|