EUCTR2009-011346-26-DE进行中（未招募）不适用
A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,550
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. In-patient at a Neonatal Intensive Care Unit (NICU)
- •2. Informed consent obtained from the legally authorized representative(s)
- •3. Less than 48 hours after birth at the time of initiation of the first infusion (first infusion to be given as soon as possible after birth)
- •4. Birth weight from 600 grams to 1200 grams
- •5. Estimated gestation age =33 weeks as determined by the neonatologist
- •6. Existing intravenous access at the time of first infusion
- •For multiple gestations, twins or triplets may be enrolled for each subject that meets the entry criteria. These subjects will be individually randomized like other subjects in the study.
- •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. Infants with proven staphylococcal sepsis as per this protocol prior to randomization
- •2. Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk
- •3. Currently receiving, recently received, or planned to receive other agents (e.g., investigational or IVIG) that could interfere with conduct, results or interpretation of this study
- •4. Severe congenital or chromosomal anomaly that would limit life expectancy or require corrective measures during the period of this study
- •5. Uncontrolled seizures
研究者
相似试验
进行中（未招募）
不适用
A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis - BSYX-A110Prevention of Staphylococcal Sepsis in Very Low Birth Weight (VLBW) NeonatesMedDRA version: 9.1Level: LLTClassification code 10040049MedDRA version: 9.1Level: LLTClassification code 10056430EUCTR2009-011346-26-ITBIOSYNEXUS INC1,550
进行中（未招募）
不适用
A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal SepsisPrevention of Staphylococcal Sepsis in Very Low Birth Weight (VLBW) NeonatesMedDRA version: 12.0Level: LLTClassification code 10040049Term: Sepsis neonatalMedDRA version: 12.0Level: LLTClassification code 10056430Term: Staphylococcal sepsisEUCTR2009-011346-26-GBBiosynexus Incorporated1,550
招募中
1 期
Combined Dose-Finding and CV Outcomes Study with CSL300 (Clazakizumab) in Adult Subjects with ESKD Undergoing Dialysis (POSIBIL6ESKD).Atherosclerotic cardiovascular disease in patients with ESKDMedDRA version: 21.1Level: LLTClassification code: 10051615Term: Atherosclerotic cardiovascular disease Class: 10047065CTIS2022-500273-14-00CSL Behring LLC1,039
进行中（未招募）
1 期
A research study to evaluate the experimental drug AMAG-423 to see how well it works and how safe it is in women who are near child birth who develop a condition called severe preeclampsia.Severe PreeclampsiaMedDRA version: 20.0Level: LLTClassification code 10040444Term: Severe pre-eclampsiaSystem Organ Class: 100000004868EUCTR2018-004212-21-ROAMAG Pharmaceuticals, Inc.200
进行中（未招募）
1 期
A research study to evaluate the experimental drug AMAG-423 to see how well it works and how safe it is in women who are near child birth who develop a condition called severe preeclampsia.EUCTR2018-004212-21-PLAMAG Pharmaceuticals, Inc.200