EUCTR2016-001384-37-NL进行中（未招募）1 期
An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- 性别
- All
入选标准
- •? Male or female pediatric patients 6 to < 18 years of age at time of assent/consent
- •? Diagnosis of MG confirmed by positive serologic test for anti-AChR-Ab at Screening, and one of the following: history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation, or history of positive anticholinesterase test, or patient demonstrated improvement in MG signs on oral AChIs, as assessed by the Investigator
- •? Presence of refractory gMG, defined as patients with gMG who have one or more of the following: failed treatment = 1 year with at least 1 IST, require maintenance PE or IVIg to control symptoms, in the opinion of the Investigator MG poses a significant functional burden despite current MG treatment.
- •? All MG-specific treatment has been administered at a stable dosing regimen of adequate duration prior to Screening
- •? Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV at Screening
- •? In patients aged 12 to 18 years, QMG total score = 12 at Screening; in patients aged 6 to 11 years, no minimum QMG is required for inclusion; however, patients must have documented limb weakness in at least one limb.
- •? Patients must be vaccinated against meningococcal infections within the 3 years prior to, or at the time of, initiating study drug. Patients who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
- •? Documented vaccination against H influenzae and S pneumoniae infections prior to dosing as per local and country specific immunization guidelines for the appropriate age group.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •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
- •? Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for =5 years before Screening.
- •? History of thymectomy within 12 months prior to Screening.
- •? Weakness only affecting ocular or periocular muscles (MGFA Class I).
- •? Myasthenia Gravis crisis or impending crisis at or during Screening (MGFA Class V).
- •? 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.
- •? Unresolved meningococcal infection
- •? Patients who are under 15 kg and are receiving maintenance
- •? For patients who are not receiving a stable maintenance dose of IVIg, use of IVIg (eg, as rescue therapy) within 4 weeks prior to first dose
- •? Use of PE within 4 weeks prior to first dose
- •? Use of rituximab within 6 months prior to first dose
- •? Hypersensitivity to murine proteins or to one of the excipients of eculizumab
研究者
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