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A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, in Paediatric Patients With Primary Haemophagocytic Lymphohistiocytosis

Trial Profile

A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, in Paediatric Patients With Primary Haemophagocytic Lymphohistiocytosis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Oct 2019

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At a glance

  • Drugs Emapalumab (Primary)
  • Indications Haemophagocytic lymphohistiocytosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors NovImmune SA
  • Most Recent Events

    • 19 Mar 2019 This trial has been completed in Sweden, according to European Clinical Trials Database.
    • 19 Mar 2019 This trial has been completed in Sweden, according to European Clinical Trials Database.
    • 26 Feb 2019 According to a Swedish Orphan Biovitrum media release, data from the study were presented at the 2019 Transplantation and Cellular Therapy (TCT) Meetings.
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