A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 69
- 主要终点
- The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
研究概览
简要总结
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile.
The study takes place during a single visit, at the time of patient enrollment in the study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with severe haemophilia A defined as residual factor VIII activity < 1%
- •or Patient with moderate haemophilia A (residual factor VIII activity >1% and <5%) with severe clinical profile
- •Patient treated in prevention with the same plasma or recombinant factor VIII for at least 6 months
- •Patient whose inclusion visit is performed during a routine visit including a measurement of plasma residual factor VIII :c level
- •In the medical file (retrospective data) the pharmacokinetic parameters are available and have been obtained from a PK analysis of factor VIII level performed with the same anti haemophilic factor than the one used on the inclusion day
排除标准
- •Patients with haemophilia B
研究组 & 干预措施
Group 1
干预措施: Recombinant Factor VIII (Kogenate FS, BAY14-2222) (Drug)
结局指标
主要结局
The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
时间窗: after 1 month
The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
时间窗: after 1 month
The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
时间窗: after 1 month
次要结局
- The dosage of factor VIII calculated by OPTIMS calculator(within 48 hours after enrollment)
- The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire(within 48 hours after enrollment)