CTIS2023-507817-85-00进行中（未招募）1 期
A Phase III, Multicenter, Open-Label, Uncontrolled Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients with AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) - WN41733
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 clinical trial of medicinal product
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •1. Age at screening 2-11 years, inclusive, 2. Body weight at screening =10 kg, 3. For female participants of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception, 4. Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria, 5. Neurological stability for =30 days prior to both screening and baseline, 6. Normal or abnormal neurologic status as described by EDSS (0 to 6.5)
排除标准
- •1. Pregnancy or lactation, 2. Evidence of other demyelinating disease mimicking NMOSD including but not limited to MS, myelin oligodendrocyte glycoprotein-IgG associated disease, or progressive multifocal leukoencephalopathy, 3. Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection (excluding fungal infection of nail beds or dental caries) at baseline, 4. Evidence of chronic active hepatitis B or C, 5. Evidence of untreated latent or active tuberculosis (TB), 6. Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
研究者
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