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?) Monoclonal Antibody, in Paediatric Patients with Primary Haemophagocytic Lymphohistiocytosis (HLH)

ovImmune SA0 个研究点目标入组 38 人2012年10月8日

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注册库

who.int

开始日期

2012年10月8日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

ovImmune SA

•1\. Primary HLH patients of both genders, up to and including 18 years at diagnosis of HLH, or at an age appropriate to be treated in the investigator's practice. The diagnosis must be made on the following criteria (as per HLH\-2004 protocol):
•a. A molecular diagnosis or familial history consistent with primary HLH OR
•b. 5 out of 8 criteria below are fulfilled:
•\- Splenomegaly
•\- Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin \<90g/L; platelets \<100x10^9/L; neutrophils \<1x10^9/L)
•\- Hypertriglyceridemia (fasting triglycerides \>3mmol/L or \>265mg/dL) and/or hypofibrinogenemia (\=1\.5g/L)
•\- Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
•\- Low or absent natural killer (NK)\-cell activity
•\- Ferritin \=500µg/L
•\- Soluble CD25 (sCD25; i.e. soluble IL\-2 receptor) \=2400U/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, expect for rituximab in case of documented B\-cell EBV infection
•4\. Active mycobacteria, Histoplasma Capsulatum,Shigella, Campylobacter, Leishmania or Salmonella infections.
•5\. Evidence of past 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\. Patient who have another concomitant disease or malformation severely affecting the cardiovascular, pulmonary, liver or renal function.