Evaluation of Blood Glucose Levels for Hepatitis B Immune Globulin (HepaGam B) Administration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
时间窗: 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).
次要结局
未报告次要终点