Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The level of Factor VIII in pMols
研究概览
简要总结
A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting factor manufacturers, physicians and patients.
详细描述
Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional activated partial thromboplastin time (APTT) assay. A PK study in seven study subjects with hemophilia A is being carried out using five different commercially licensed factor VIII concentrates and the blood samples drawn for the PK analysis are being measured for FVIII with the novel assay and compared with the standard APTT assay. The concentrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •adults with hemophilia A
- •factor VIII less that 2%
- •informed consent signed
- •absence of an inhibitor
排除标准
- •history of a high responding inhibitor anemia
研究组 & 干预措施
FVIII immuno-assay
The study is not designed as a therapeutic evaluation, but an assessment of clotting factor VIII timed responses after the infusion of specified doses of licensed clotting factor VIII concentrates. The purpose of the study is to measure the levels of infused licensed clotting factor VIII by standard assay techniques and comparing these standard assays with an experimental assay. Measurements of possible co-factors that might impact the results were also carried out.
干预措施: FVIII immuno-assay (Other)
结局指标
主要结局
The level of Factor VIII in pMols
时间窗: 48 hours
次要结局
- The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels(48 hours)
研究者
Edward Gomperts
Attending Hematologist
Children's Hospital Los Angeles