Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

Status:	Recruiting
Conditions:	Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	Any
Updated:	2/28/2019
Start Date:	June 2013
Contact:	Cristina de Min, MD
Email:	cdemin@novimmune.com
Phone:	+41 61 201 1322

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

International, multicenter, long-term, follow-up study that will enroll HLH patients who have
received NI-0501 in a previous clinical trial, in the context of the clinical development
program for NI-0501

The aim of this study is to monitor the long-term safety profile of patients who have
previously received at least one dose of NI-0501, including survival at several time points
after the administration of NI-0501.

Moreover to study the elimination profile of NI-0501 and to assess the immunogenicity of
NI-0501.

Furthermore in the event that patients, upon request of 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.

Inclusion Criteria:

- Having received at least one dose of NI-0501.

- Having signed the Informed Consent by the patient or the patient's legal
representative(s), as applicable, with the assent of patients who are legally capable
of providing it.

Exclusion Criteria:

We found this trial at

sites

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

(919) 962-2211