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A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody

Hemophagocytic Lymphohistiocytosis Clinical Trial

Official title:
A Multicenter Study for the Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

Clinical Trial Summary

International, multicenter, long-term, follow-up study that will enrol HLH participants who have received emapalumab in previous clinical trials, in the context of the clinical development program for emapalumab or under compassionate use (CU).

Clinical Trial Description

The aim of this study is to monitor the long-term safety profile of emapalumab in participants who have previously received at least one dose of emapalumab, including survival time after the administration of emapalumab. Moreover, the elimination profile of emapalumab and the immunogenicity will also be assessed. Furthermore, safety, tolerability, efficacy, and pharmacokinetic (PK) profile of emapalumab will be closely monitored in the event that some participants, upon request of the treating physician, will receive emapalumab treatment in the follow-up study. ;

Study Design

Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytosis
  • Lymphohistiocytosis, Hemophagocytic
Clinical Trial Details
NCT number NCT02069899
Study type Interventional
Source Swedish Orphan Biovitrum
Contact
Status Completed
Phase Phase 2/Phase 3
Start date August 4, 2014
Completion date May 18, 2021
View Details
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