NCT02246881已完成3 期
An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
Bio Products Laboratory8 个研究点 分布在 2 个国家开始时间: 2001年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 8
- 主要终点
- PK parameters for FVIII:C
研究概览
简要总结
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.
排除标准
- 未提供
研究组 & 干预措施
Optivate®
Experimental
Optivate® (Human Coagulation Factor VIII)
干预措施: Optivate® (Human Coagulation Factor VIII) (Biological)
Current Factor VIII
Active Comparator
Optivate® (Human Coagulation Factor VIII)
干预措施: Optivate® (Human Coagulation Factor VIII) (Biological)
结局指标
主要结局
PK parameters for FVIII:C
时间窗: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
2 期
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.vonWillebrand's DiseaseNCT02250508Bio Products Laboratory
已完成
1 期
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency AnaemiaIron DeficiencyAnaemiaNCT06080555Sichuan Huiyu Pharmaceutical Co., Ltd84
撤回
1 期
A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy ParticipantsHealthy ParticipantsNCT06061523Amgen
已完成
1 期
A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic ImpairmentHepatic ImpairmentNCT01767948Janssen Research & Development, LLC30
已完成
1 期
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy ParticipantsHealthyNCT01866007Janssen Research & Development, LLC141