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临床试验/CTIS2023-506942-22-01
CTIS2023-506942-22-01进行中(未招募)1 期

Early immunotherapy with intravenous immunoglobulin, cyclophosphamide and methylprednisolone in patients with anti-Hu-associated paraneoplastic sensory neuropathy (NESPA). - APHP230701

Assistance Publique Hopitaux De Paris0 个研究点目标入组 21 人开始时间: 2023年11月10日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
21

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Adult patients with anti-Hu antibody paraneoplastic sensory neuropathy, Age = 18 years old, Possible sensory neuropathy according to the criteria of Camdessanché et al., dominant picture of sensitive ataxia (damage to the central nervous system and/or neuromuscular junction is accepted, provided that it has a minor impact on the patient's disability), Positive anti-Hu antibodies in blood and/or cerebrospinal fluid, Outpatient (Modified Rankin Score (mRS) 2 or 3), Start of neurological symptoms less than 3 months ago, Inform consent Free, written and signed, Registered with a social security scheme or beneficiary (except AME)

排除标准

  • Known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients, Patients unable to complete the follow-up required by the study, Patients under tutorship or curatorship, Patient deprived of liberty by a judicial or administrative decision, Absolute contraindications to IVIg: selective IgA deficiency, known thrombophilia, patients suffering from type I or II hyperprolinaemia, hypersensitivity to human immunoglobulins, Absolute contraindications to cyclophosphamide: yellow fever vaccination within three months of inclusion, acute urinary tract infection, acute bone marrow failure, More than two courses of intravenous Immunoglobulins administered in the 3 months prior to recruitment, Other concomitant immunotherapy, Other causes of immunodepression (acquired or congenital), Treatment with checkpoint inhibitors in progress or completed less than 3 months previously, Women of childbearing age without effective contraception, pregnant or breastfeeding, History of psychiatric or general illness that may contraindicate treatment

研究者

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