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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: 05 Nov 2024

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At a glance

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

Most Recent Events

  • 30 Oct 2024 According to a Swedish Orphan Biovitrum media release, In the USA, emapalumab is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).
  • 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.

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