EUCTR2019-000201-69-EE进行中（未招募）1 期
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
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
- 1,500
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
- •Subjects must meet all of the following criteria:
- •1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born = 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:
- •(a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
- •(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
- •2. For the CLD/CHD cohort:
- •(a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
- •(b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (= 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
- •3. Infants who are entering their first RSV season at the time of screening
- •4. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
- •5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
- •6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1500
- •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 of the following would exclude the subject from participation in the study:
- •1. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- •2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
- •3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- •4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
- •5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
- •6. Anticipated cardiac surgery within 2 weeks after randomization
- •7. Anticipated survival of < 6 months after randomization
- •8. Receipt of any investigational drug
- •9. Known renal impairment
- •10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- •11. Clinically significant congenital anomaly of the respiratory tract
- •12. Chronic seizure, or evolving or unstable neurologic disorder
- •13. Prior history of a suspected or actual acute life-threatening event
- •14. Known immunodeficiency, including human immunodeficiency virus (HIV)
- •15. Mother with HIV infection (unless the child has been proven to be not infected)
- •16. Any known allergy, including to immunoglobulin products, or history of allergic reaction
- •17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
- •18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
- •19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
- •20. Concurrent enrollment in another interventional study
- •21. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals
研究者
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