Clinical Trial: Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief Summary: 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
Detailed Summary:
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.
Sponsor: NovImmune SA
Current Primary Outcome: Safety Endpoints [ Time Frame: Up to 12 months post transplant ]
The incidence, intensity, possible relationship to NI-0501 and outcomes of adverse events, serious and non-serious, will be assessed throughout the study.
Vital signs, physical examination and laboratory values: evolution over time.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NovImmune SA
Dates:
Date Received: December 23, 2013
Date Started: June 2013
Date Completion:
Last Updated: February 7, 2017
Last Verified: February 2017
