NCT04777422进行中（未招募）2 期
A Pilot Study to Determine the Safety of Defibrotide in Children With High Risk Kawasaki Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Number of patients with grade III/IV allergic reaction to defibrotide
研究概览
简要总结
This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kawasaki disease presumptive diagnosis defined according AHA criteria;
- •Signed informed consent and patient assent (if applicable)
- •Diagnosis of KD and initiation of defibrotide within 96 hours from the conclusion of IVIG treatment
- •Age: 0 - 11 years old
- •High risk category defined as patient meeting ≥2 of the following criteria: male, age <6 months or >8yrs, IVIG-resistance, Fever lasting greater than 10 days, prior to diagnosis, Coronary artery aneurysms, and/or Laboratory tests indicating worse systemic inflammation
- •PT and PTT within institutional normal limits
- •Platelet count ≥100,000/mm3
排除标准
- •History of Grade III or IV hemorrhage or active bleeding;
- •Previous Grade II-IV hypersensitivity to defibrotide
- •Current systemic anti-coagulant therapy and/or fibrinolytic therapy, excluding aspirin (5 mg/kg/dose maximum).
- •Patients on an active experimental trial for Kawasaki disease
研究组 & 干预措施
Interventional
Experimental
Defibrotide 6.25 mg/kg IV q6h
干预措施: Defibrotide (Drug)
结局指标
主要结局
Number of patients with grade III/IV allergic reaction to defibrotide
时间窗: 30 days
All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration.
Number of patients with grade III/IV hemorrhage attributable to defibrotide
时间窗: 42 days
All patients will be monitored for hemorrhage probably or definitely related to defibrotide.
次要结局
- Number of patients with improvement in clinical progression/signs of Kawasaki disease(42 days)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
3 期
A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)Kawasaki DiseaseSteroidImmuoglobulinNCT03200561National Taiwan University Hospital100
已完成
2 期
Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of DefibrotideHepatic Veno-Occlusive DiseaseNCT00272948European Society for Blood and Marrow Transplantation360
招募中
3 期
A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG TreatmentKawasaki DiseaseNCT04656184Assistance Publique - Hôpitaux de Paris84
已完成
1 期
Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery AbnormalitiesKawasaki DiseaseNCT01431105University of California, San Diego34
进行中（未招募）
2 期
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki DiseaseKawasaki DiseaseCoronary AneurysmNCT01917721Hawaii Pacific Health26