EUCTR2021-003221-30-ES进行中（未招募）1 期
A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children = 24 Months of Age - MUSIC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1.Neonate, infant, or young child = 24 months of age who, per investigator judgment, are:
- •(a)In their first year of life AND entering their first RSV season at the time of dose administration
- •(b)In their second year of life AND entering their second RSV season at the time of dose administration
- •2.The subject must meet at least 1 of the following conditions at the time of informed consent.
- •(a)Diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M [IgM] syndrome, etc); antibody deficiency (X linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndromes, etc); or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc), or
- •(b)Diagnosed with human immunodeficiency virus infection, or
- •(c)History of organ or bone marrow transplantation, or
- •(d)Subject is receiving immunosuppressive chemotherapy, or
- •(e)Subject is receiving systemic high-dose corticosteroid therapy (prednisone equivalents = 0.5 mg/kg every other day, other than inhaler or topical use), or
- •(f)Subject is receiving other immunosuppressive therapy (eg, azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc)
- •All efforts will be made to recruit subjects for representation across all the immunocompromised conditions indicated in inclusion criteria (a) - (f).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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
- •1.Subject who meets any of the indications other than (including those approved for palivizumab in Japan) the immunocompromised conditions below.
- •(a)Subject born at = 28 weeks gestation and is = 12 months of age
- •(b)Subject born at 29 to 35 weeks gestation and is = 6 months of age
- •(c)Age = 24 months with a history of bronchopulmonary dysplasia requiring medical management within the past 6 months
- •(d)Age = 24 months with current hemodynamically significant CHD
- •(e)Age = 24 months with Down syndrome
- •2.Requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, or other mechanical respiratory or cardiac support at screening.
- •3.A current, active infection, including RSV infection, at the time of screening or at the time of investigational product administration.
- •4.Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration.
- •5.Any serious concurrent medical condition (renal failure, hepatic dysfunction, suspected active or chronic hepatitis infection, seizure disorder, unstable neurologic disorder, etc), except those resulting in an immune deficiency condition.
- •6.Clinically significant congenital anomaly of the respiratory tract.
- •7.Receipt of palivizumab.
- •8.Any known allergy or history of allergic reaction to any component of nirsevimab.
- •9.Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins.
- •10.Concurrent enrollment in another interventional study, or prior receipt of any investigational agent.
- •11.Anticipated survival of less than 1 year at the time of informed consent.
研究者
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