EUCTR2021-005752-10-IT进行中（未招募）1 期
A Phase 1b, Randomized, Blinded, Dose-Determined Study Evaluating the Safety and Tolerability Profile of Intervention with AT-100 (rhSP-D) in Preterm Neonates at High Risk for the Development of Bronchopulmonary Dysplasia (BPD) - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- 性别
- All
入选标准
- •1. Inpatient preterm neonates born between GA 25 to 28 6/7 weeks, inclusive, for the dose escalation cohorts; GA 23 to 28 6/7 weeks, inclusive, for the latter cohort receiving the highest-tolerated and safest tested dose.
- •2. Intubated and on mechanical ventilation.
- •3. Receiving at least 1 dose of standard-of-care-indicated surfactant treatment (Curosurf®) after birth, and able to receive the first dose of AT-100 or air-sham within 96 hours of birth given at any point after 15 minutes following any of the the subject's Curosurf® dose(s).
- •4. Parent or legal guardian (as per local laws governing birth & neonate decision rights) is able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
- •5. Parent or legal guardian is able to understand and sign a consent or authorization form, which shall permit the use, disclosure, and transfer of the subject's personal health information (e.g., in the USA, Health Information Portability and Accountability Act [HIPAA] Authorization form).
- •6. Parent or legal guardian is willing and able to have neonate complete all trial procedures and successfully complete the trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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. Weight at time of birth < 400 g or > 1,800 g.
- •2. Major apparent congenital abnormalities impacting cardio and pulmonary function such as, but not limited to:
- •a. congenital diaphragmatic hernia,
- •b. congenital pulmonary airway malformation,
- •c. omphalocele, or
- •d. known or suspected cyanotic congenital heart disease (i.e., tetralogy
- •of fallot, transposition of the great arteries, etc.).
- •3. Active DNR (Do Not Resuscitate) order in place.
- •4. Known pulmonary air leaks (e.g., pneumothorax or pneumomediastinum) at the time of AT-100 or air-sham administration.
- •5. History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100).
- •6. AT-100 or air-sham dosing was set to occur before DSMC recommendation to proceed to the next dose-escalation cohort.
- •7. Use of minimally invasive surfactant administration techniques (e.g., LISA, MIST) or INSURE or if, in the opinion of the care team, the infant is very likely to be extubated shortly after receiving Curosurf.
- •a. Subjects extubated and re-intubated after their Curosurf dose(s) are eligible, so long as the subject meets Inclusion#3.
- •8. Birth mother:
- •a. Has known active Hepatitis B, C, or E diagnosis.
- •b. Has known illness or exposure that, in the judgement of the
- •Investigator, is serious enough to induce an immune deficiency such as
- •Human Immunodeficiency Virus (HIV) and/or is receiving
- •chemotherapy.
- •c. Has known active Sexually Transmitted Infection (STI) (i.e., Herpes Simplex Virus [HSV] with known active lesions; HIV; current Syphilis, Gonococcal, or Chlamydial infection that has not been treated)
- •d. Has known Cytomegalovirus (CMV) active infection (not including CMV-carrier).
- •e. Has known history or evidence of alcohol or drug abuse, with the exception of marijuana/marijuana-based products/THC, based on a positive maternal or infant drug screen as evidenced by the institution's standard-of-care practice.
- •9. For the neonate, concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care or participation in such a trial within the last 30 days (or 5 half-lives of an investigational product) prior to birth or up to Week 36 PMA.
- •10. Any condition or situation which, in the Investigator's judgement, puts the mother or the neonate at significant risk, could confound the trial results, or may interfere
- •significantly with the mother's or neonate's participation in the trial.
- •11. Symptomatic and confirmed COVID-19 infection of the mother around the time of birth.
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