NL-OMON54546招募中不适用
Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To Wi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •- No minimum or maximum age at inclusion date;
- •- Hemorrhagic symptoms or a family history of von Willebrand disease with
- •historically lowest levels of VWF:Ag <0.60 IU/ml and/or VWF:Act <0.60 IU/ml
- •and/or VWF:CB <0.60 and/or FVIII <0.40 IU/ml;
- •- Need for DDAVP-testing (arm A); and/or
- •- Need for a medical intervention requiring DDAVP and/or VWF replacement
- •therapy (arm B) (arm B); or
- •- (Future) Bleeding requiring DDAVP and/or VWF replacement therapy (arm C); or
- •- Receiving or requiring prophylaxis with VWF-containing concentrate due severe
- •and/or recurrent bleeding episode (arm D).
- •- Written patient (and in case of a patient <16 years of age, parental)
- •informed consent.
排除标准
- •- Any other known hemostatic abnormalities;
- •- Acquired VWD;
- •- Presence of VWF antibodies (>0.2 BU)
- •- Withdrawal of (parental) informed consent.
研究者
相似试验
进行中（未招募）
1 期
Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850HemophiliaEUCTR2018-003869-33-NLErasmus University Medical Center50
尚未招募
不适用
Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patientsNL-OMON27791Erasmus Medical Center, Sophia Children's Hospital50
尚未招募
不适用
Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.hemophiliaNL-OMON55874Erasmus MC, Universitair Medisch Centrum Rotterdam50
进行中（未招募）
1 期
Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand diseaseVon Willebrand diseaseMedDRA version: 20.0Level: LLTClassification code 10055168Term: Von Willebrand's factor deficiencySystem Organ Class: 100000004850EUCTR2018-001631-46-NLErasmus University Medical Center120
已完成
不适用
Development of a method for better estimation of warfarin dose in patients requiring warfarin therapyCTRI/2018/06/014614Dr Nusrat Shafiq82