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

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Trial Summary
Trial Overview
Inclusion Criteria

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
9
sites
Children's Healthcare of Atlanta
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Shanmuganathan Chandrakasan, MD
Phone: 404-727-8877
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Kimberly Kasow, MD
Phone: 919-962-8733
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Timothy Garrington, MD
Phone: 720-777-6740
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts 02115
Principal Investigator: Barbara A Degar, MD
Phone: 617-632-5186
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Boston, MA
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Cincinnati Children's Hospital - Division of Immunobiology
Cincinnati, Ohio 45229
Principal Investigator: Michael Jordan, MD
Phone: 513-636-7287
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Cincinnati, OH
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Texas Children'S Cancer Center
Houston, Texas 77030
Principal Investigator: Carl Allen, MD, PhD
Phone: 832-824-4312
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Houston, TX
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University Children's Hospital Münster Department of Pediatric Hematology and Oncology
Münster, 48149
Principal Investigator: Claudia Rössig, Prof. Dr. Med.
Phone: 0049 2518347742
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Münster,
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Primary Children's Hospital
Salt Lake City, Utah 84143
Principal Investigator: Mark N Fluchel, MD
Phone: 801-662-4710
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Salt Lake City, UT
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Alfred I. duPont Hospital for Children Nemours Center for Cancer and Blood Disorders
Wilmington, Delaware 19803
Principal Investigator: Jonathan Powell, MD
Phone: 302-651-5500
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Wilmington, DE
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