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
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
- 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.