JAKAHDI - JAK inhibitors in acquired hemophagocytic syndrome in the IC

Phase 1

• Conditions: Adult patients older than 18 years. Patients admitted to the participating ICUs will be included in this study if the meet eligibility criteria.; MedDRA version: 21.1Level: LLTClassification code: 10058125Term: Haemophagocytic syndrome Class: 10021428; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2023-504513-77-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion 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.

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified