Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Incyte Corporation

Criteria

Inclusion Criteria:

• Patients age > 18 years,

• Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol

• Patient known to have systemic juvenile idiopathic arthritis are classified as having HLH

• Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the duration of the study

• Be either affiliated to, or a beneficiary of, a social security category

Exclusion Criteria:

• Organ failure: confusion, organic kidney failure KDIGO 2 criteria, liver failure (Factor V < 50%), heart failure, respiratory failure.

• Fibrinogen < 0.50 g/l, platelets <20G/L

• Indication to intensive care unit transfer on an organ failure requiring assistance (dialysis, Ventilation (assisted or VNI), shock regardless of the origin.

• Breastfeeding women

• Patient participating in another investigational therapeutic study

• Women with a positive pregnancy test or not willing to take contraceptive measures

• Known allergies, hypersensitivity, or intolerance to any of the ITACITINIB or excipients, or similar compounds

• Current or history of recurrent infections, including HBV, HCV

• Participants with active HBV or HCV infection that requires treatment or who are at risk for HBV reactivation (ie Positive HBs Ag serology)

• Candidates positive for HCV antibody and positive PCR RNA HCV

• HIV infection with positive viral charge

• Protected adults (including individual under guardianship by court order)

• Vulnerable adults, under a safeguard of justice measure

• Adults deprived of their liberty by judicial or administrative decision

• Persons under psychiatric care without their consent

• Persons admitted to social institution for purposes other this research

• Adults under legal protection (guardianship or curatorship)

• Persons unable to express their consent