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JAKAHDI - JAK inhibitors in acquired hemophagocytic syndrome in the ICU
EU CTIS ID: 2023-504513-77-00
What this study is testing
To demonstrate that ruxolitinib, in association with standard of care, may reverse organ failure (as represented by SOFA score) better than standard of care alone in critically ill patients with acquired HS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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).
You likely can't join if
- - 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);
See the full eligibility criteria
- - 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.
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.