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

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Jun 2017

At a glance

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

    • 07 Feb 2017 Planned primary completion date changed from 1 Dec 2016 to 1 Dec 2017.
    • 19 Jan 2017 This trialhas been completed in Austria as per European Clinical Trials Database record.
    • 23 Jun 2016 Safety as a primary endpoint removed from the study. Hence trial focus is only on Therapeutic use.
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