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临床试验/CTIS2023-504513-77-00
CTIS2023-504513-77-00进行中(未招募)1 期

JAKAHDI - JAK inhibitors in acquired hemophagocytic syndrome in the ICU - APHP220919

Assistance Publique Hopitaux De Paris0 个研究点目标入组 42 人开始时间: 2023年7月7日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
42

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
18 至 65+(—)
性别
All

入选标准

  • adult patients older than 18 years, - acquired hemophagocytic syndrome, regardless of etiology, defined by the presence of 5 or 6 HLH-2004 criteria or HScore = 200, - admission in the ICU, - need for symptomatic treatment of HS in relation with organ failure, as defined by SOFA score = 4, - Informed consent signed: •by the patient, •Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent in written as per L1111-6,, - Or in an emergency situation and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow)., - The inclusion of women of childbearing potential requires the use of a highly effective contraceptive measure. Contraception should be maintained during treatment and one day after.

排除标准

  • -Moribund, defined by a life expectancy < 48 hours;, -Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up, -Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice), -Patients deprived of their liberty by a judicial or administrative decision, -Participation in another interventional research, -Pregnant or lactating patients (women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry);, -No affiliation to health insurance;, -Known hypersensitivity to ruxolitinib;, -Lactose intolerance;, -Hypersensitivity to cellulose, microcrystalline; magnesium stearate; silica, colloidal anhydrous; sodium starch glycolate (Type A); povidone K30; hydroxypropylcellulose 300 to 600 cps,, -Pre-existing decisions of withholding/withdrawing care,, -History of progressive multifocal leukoencephalopathy, -Uncontrolled cutaneous cancer

研究者

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