EUCTR2019-001829-26-ES进行中（未招募）1 期
A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male or female patients aged 2 years to < 18 years at time of assent/consent.
- •Anti-AQP4 Ab-positive and diagnosis of NMOSD as defined by the 2015 IPND criteria
- •Historical Relapse Rate of at least 2 relapses in the last 2 years, and with at least 1 relapse in the year prior to Screening.
- •Expanded Disability Status Scale score = 7
- •Patients who enter the study receiving supportive immunosuppressive therapies for the prevention of relapse, either in combination or monotherapy, must be on a stable dosing regimen of adequate duration prior to Screening.
- •Vaccinated against N meningitidis within 3 years prior to, or at the time of initiating eculizumab. Patients who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics until 2 weeks after the vaccination.
- •Documented vaccination against Hib and S pneumoniae infections 2 weeks prior to dosing as per local and country-specific immunization guidelines for the appropriate age group.
- •Willing and capable to give informed assent (if applicable, as determined by the central Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) and in accordance with local requirements) and whose parent/legal guardian are willing and able to give written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients known to be human immunodeficiency virus (HIV) positive or with congenital immunodeficiency.
- •Unresolved meningococcal or other serious infection.
- •Any unresolved acute or chronic systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics.
- •Hypersensitivity to murine proteins or to one of the excipients of eculizumab.
- •Use of rituximab or other biologicals such as tocilizumab within 6 months prior to Screening.
- •Use of mitoxantrone within 3 months prior to Screening.
- •Use of intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 3 weeks prior to Screening.
- •Use of immunomodulatory therapies for multiple sclerosis within 3 months prior to Screening.
研究者
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