EUCTR2017-000408-71-Outside-EU/EEA进行中（未招募）1 期
A Phase II/Ill, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine inPreterm Subjects Ages 28 Weeks to < 36 Weeks Gestational Age
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hospira Inc
- 入组人数
- 6
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
- •Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting
- •anticipated to require at least 6 hours of continuous IV sedation.
- •2. Age: subjects had to be in the following age range at screening:
- •Preterm subjects z 28 weeks through < 36 weeks, gestational age;
- •Note: Gestational age (in weeks) was calculated as follows: the time elapsed between the first
- •day of the last menstrual period and the day of enrollment. 14
- •3. Weight: subject's weight at the time of enrollment had to be > 1000 g.
- •4. Subject's parent(s) or legal guardian(s) had voluntarily signed and dated the informed consent
- •document approved by the IRB/ IEC.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •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. Neonate subjects with neurological conditions that prohibited an evaluation of sedation such as:o Diminished consciousness from increased intracranial pressure.
- •O The presence of catastrophic brain injury or other severe mental disorders that would make
- •responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
- •O Subjects with immobility from neuromuscular disease or continuous infusion of
- •neuromuscular blocking (NMB) agents.
- •2. Subjects with second degree or third degree heart block unless subject has a pacemaker or
- •pacing wires were in situ.
- •Note: If subject's status-post Cardiopulmonary Bypass (CPB) was being managed without
- •pacing wires in situ, the subject could not have been suspected to be in second degree or
- •third degree heart block at the time of DEX administration.
- •3. HR < 120 bpm prior to the initiation of DEX.
- •4. Exposure to any investigational drug within 30 days prior to DEX administration.
- •5. Previous exposure to DEX as part of an investigational study.
- •6. In subjects that were ex-utero for less than 72 hours, a maternal history of poly-substance drug
- •abuse, based upon the Investigator's clinical judgment.
- •7. At the discretion of the Investigator, subjects in whom the risk of DEX treatment was expected to
- •exceed its benefits.
- •8. Subjects who had a known allergy or contraindication to fentanyl, morphine, MDZ, DEX, or other
- •a-2 agonists.
- •9. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain
- •control.10. Screening Alanine Aminotransferase (ALT) levels > 115 UIL.
研究者
相似试验
进行中（未招募）
1 期
An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects with Recurrent or Unresectable Giant Cell Tumor (GCT) of BoneEUCTR2006-006964-48-FRAmgen Inc34
进行中（未招募）
1 期
A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study ofDexmedetomidine in Neonates Ages = 28 Weeks to = 44 Weeks Gestational AgeEUCTR2017-000406-38-Outside-EU/EEAHospira Inc42
进行中（未招募）
1 期
Study of the efficacy, safety, tolerability and drug blood levlrs of ANF-RHO to treat patients with low white blood cells countChronic neutropeniaMedDRA version: 20.0Level: LLTClassification code 10066702Term: Chronic neutropeniaSystem Organ Class: 100000013471EUCTR2016-004539-18-FRProlong Pharmaceuticals, LLC10
进行中（未招募）
1 期
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2011-002415-28-BGCSL Behring GmbH60
进行中（未招募）
不适用
A safety and Efficacy Study of a recombinant Factor IX in patients with severe Hemophilia BEUCTR2011-002415-28-ESCSL Behring GmbH60