NL-OMON54896撤回3 期
AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS - ECU-MG-303
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 2
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
- 2 至 17（—）
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:
- •a. History of abnormal neuromuscular transmission test demonstrated by
- •single-fiber electromyography or repetitive nerve stimulation, or
- •b. History of positive anticholinesterase test (eg, edrophonium chloride or
- •neostigmine test), or
- •c. 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:
- •a. Failed treatment * 1 year with at least 1 IST
- •b. Require maintenance PE or IVIg to control symptoms
- •c. 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
- •* 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.
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
- •* 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 IVIg.
- •* For patients who are not receiving a stable maintenance dose of IVIg, as
- •described in the Inclusion Criteria, 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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