NI-0501-05

Principal Investigator: Mark Fluchel
Keywords: Treatment , NI0501 , Monoclonal Department: Pediatric Administration
IRB Number: 00082348 Co Investigator:  
Specialty: Clinical Immunology/Immunodeficiency
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Deveree Partridge
deveree.partridge@hsc.utah.edu
801-662-4710

Brief Summary

  • To monitor the long-term safety profile of patients who have received at least one dose of NI-0501
  • To assess HLH patients' survival at several time points after the administration of NI-0501, such as prior and after transplantation, and up to one year after transplantation
  • To study the elimination profile of NI-0501
  • To assess the immunogenicity of NI-0501

In the event that patients, upon request from the treating physician, will be maintained on NI-0501 treatment beyond the foreseen 8 weeks, NI-0501 safety, tolerability, efficacy and PK profile will be closely monitored in these patients until treatment discontinuation. Please note, the treating physicians involved with the NI-0501-04 treatment protocol (IRB# 81572) are the same investigators on this long term follow up protocol, so care would not be transitioned to new physicians in this instance. 

Inclusion Criteria

The study population comprises of HLH patients who have received at least one dose of NI-0501 in the context of the clinical development program for NI-0501.
 
Patients must fulfill the following inclusion criteria:
1. Having received at least one dose of NI-0501.
 
2. Having signed the Informed Consent of this study by the patient or the patient’s legal representative(s), as applicable, with the assent of patients who are legally capable of providing it.
 
3. Having agreed to continue using adequate methods of birth control until 6 months after the last administered dose of NI-0501, when relevant.

Exclusion Criteria

There are no exclusion criteria.