A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (Anti-IFN Gamma) Monoclonal Antibody, in Paediatric Patients with Primary Haemophagocytic Lymphohistiocytosis (HLH)

ovImmune SA0 个研究点目标入组 38 人2013年2月15日

概览

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注册库

who.int

开始日期

2013年2月15日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

ovImmune SA

•1\. Primary HLH patients of both genders, up to and including 18 years at diagnosis of HLH. The diagnosis of HLH must be made on the basis of the following criteria (as per HLH\-2004 protocol):
•a. A molecular diagnosis or familial history consistent with primary HLH
•b. Five out of the eight criteria below are fulfilled:
•\- Splenomegaly
•\- Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin \< 90 g/L; platelets \< 100 x 109/L; neutrophils \< 1 x 109/L)
•\- Hypertriglyceridemia (fasting triglycerides \> 3 mmol/L or \> 265 mg/dL) and/or hypofibrinogenemia (\<\= 1\.5 g/L)
•\- Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
•\- Low or absent natural killer (NK)\-cell activity
•\- Ferritin \>\= 500 microg/L
•\- Soluble CD25 (sCD25; i.e. soluble IL\-2 receptor) \>\= 2400 U/mL.

•1\. Diagnosis of secondary HLH consequent to a proven rheumatic or neoplastic disease.
•2\. Body weight \< 3 kg.
•3\. Patients treated with:
•any T\-cell depleting agents (such as anti\-thymocyte globulin \[ATG], anti\-CD52\) during the previous 2 weeks prior to screening
•any other biologic drug within 5 times their defined half\-life period, except for rituximab in case of documented B\-cell EBV infection (a list of some of the most commonly used biologic half\-lives will be included in the Study Specific Risk Management Plan)
•4\. Active mycobacteria, Shigella, Histoplasma capsulatum, Campylobacter, Leishmania or Salmonella infections.
•5\. Evidence of history of tuberculosis or of latent tuberculosis.
•6\. Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies.
•7\. Presence of malignancy.
•8\. Patients who have another concomitant disease or malformation severely affecting cardiovascular, pulmonary, liver or renal function.