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An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis

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Trial Profile

An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2025

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At a glance

  • Drugs Emapalumab (Primary)
  • Indications Haemophagocytic lymphohistiocytosis
  • Focus Therapeutic Use
  • Sponsors Swedish Orphan Biovitrum

Most Recent Events

  • 05 Dec 2025 According to Sobi media release, post-hoc analysis of this study with other 2 prospective studies (NI-0501-04, NI-0501-05) will be shared in 2 Poster sessions at the 65th American Society of Hematology (ASH) Annual Meeting, taking place on 6 - 9 December in Orlando, Florida.
  • 23 Sep 2023 This trial has been completed in Spain, according to European Clinical Trials Database record.
  • 06 Sep 2023 This trial has been completed in Italy according to European Clinical Trials Database record.

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