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Completed
NCT05744063
A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients
Conditions: Primary Hemophagocytic Lymphohistiocytosis
Sex: All
Healthy volunteers: No
Phase: PHASE4
Enrollment: 13
Sponsor: Swedish Orphan Biovitrum
Location: Swedish Orphan Biovitrum Research site Shanghai Fudan
Summary
The goal of this post-authorization study is to describe safety and efficacy of emapalumab in treatment experienced Chinese patients with pHLH.
Eligibility Criteria
Inclusion Criteria:
1. Male and female HLH patients of any age.
2. Patients diagnosed with confirmed or suspected pHLH, based on; a molecular diagnosis or familial history consistent with pHLH or fulfilment of HLH-2004 diagnostic criteria, i.e., five out of eight of the criteria below:
* Fever
* Splenomegaly
* Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin \
Source: ClinicalTrials.gov (NCT05744063). StuddyBuddy aggregates publicly available trial information.