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A Multicenter Study for the Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

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Trial Profile

A Multicenter Study for the Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 24 Jan 2024

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At a glance

  • Drugs Emapalumab (Primary) ; Dexamethasone
  • Indications Haemophagocytic lymphohistiocytosis
  • Focus Adverse reactions
  • Sponsors Light Chain Bioscience; Swedish Orphan Biovitrum

    • Most Recent Events

    • 12 Dec 2023 Results of Long-term follow-up study (NCT02069899) of patients who were followed for 1 year after HSCT or last administration of emapalumab in the parent study (NCT01818492), presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 31 Mar 2023 Results (n=14) assessing the efficacy and safety of emapalumab in patients with macrophage activation syndrome from NCT02069899 and NCT03311854 studies, published in the Annals of the Rheumatic Diseases.
    • 14 Dec 2021 Results of prespecified (n=34) exploratory exposure-safety analyses that were performed on data from patients with primary HLH receiving emapalumab in the pivotal trial from pivotal phase 2/3 study (NCT01818492) and its long-term follow-up study (NCT02069899), presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
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