EUCTR2015-004228-70-SE进行中（未招募）不适用
A randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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.Gestational age =32 weeks (determined by fetal ultrasound in 1st trimester if available, first day of last menstrual period and best obstetric estimate).
- •2.Birth weight: 1,001 – 2,000 g (Cohorts A & B); 500 – 1,000 g (Cohorts C & D).
- •3.< 48 hours of age.
- •4.Written informed consent from the patient’s legally authorized representative(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •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. Participation in an additional interventional clinical trial in which an investigational drug will be administered.
- •2. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
- •3. Congenital or acquired gastrointestinal pathology.
- •4. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
研究者
相似试验
进行中（未招募）
不适用
Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthmaAsthmaEUCTR2011-005030-19-ESVectura Limited174
进行中（未招募）
不适用
Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthmaAsthmaMedDRA version: 15.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-005030-19-PLVectura Limited175
进行中（未招募）
不适用
Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2011-005030-19-BGVectura Limited174
进行中（未招募）
不适用
Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthmaAsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-005030-19-DEVectura Limited174
进行中（未招募）
不适用
Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthmaAsthmaEUCTR2011-005030-19-HUVectura Limited174