EUCTR2012-003632-23-IT
进行中（未招募）
不适用
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22日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- haemophagocytic lymphohistiocytosis
- 发起方
- ovImmune SA
- 入组人数
- 38
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
- •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)
排除标准
- •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).
结局指标
主要结局
未指定
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