EUCTR2016-003883-38-DE进行中（未招募）1 期
A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients with Septic Shock and Elevated Adrenomedullin - AdrenOSS-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Adrenomed AG
- 入组人数
- 300
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
- •1. Written informed consent by patient or legally designated representative
- •(according to country – specific regulations)
- •2. Male and female patient, age = 18 years
- •3. Body weight 50 kg – 120 kg
- •4. Bio-ADM concentration > 70 pg/ml
- •5. Patient with early septic shock (start of vasopressor therapy
- •< 12 hours)
- •6. Women of childbearing potential must have a negative pregnancy serum or urine pregnancy test before randomization
- •7. Highly effective method of contraception must be maintained for 6 months after study start by women of childbearing potential and sexually active men.
- •8. No care limitation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Moribund
- •2. Pre-existing unstable condition (e.g. a recent cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction (all < 3 months), congestive heart failure – NYHA Class IV)
- •3. Patients that required cardiopulmonary resuscitation in the last 4 weeks prior to evaluation for enrollment
- •4. Severe COPD with chronic oxygen need at home (GOLD IV)
- •5. Any organ or bone marrow transplant within the past 24 weeks
- •6. Uncontrolled serious hemorrhage (= 2 units of blood / platelets in the previous 24 hrs.). Patients may be considered for enrollment if bleeding has stopped and patient is otherwise qualified
- •7. Uncontrolled hematological / oncological malignancies
- •8. Absolute neutropenia < 500 per µL
- •9. Severe chronic liver disease (Child-Pugh C)
- •10. Systemic fungal infection or active tuberculosis
- •11. Neuromuscular disorders that impact breathing / spontaneous ventilation
- •12. Burns > 30% of body surface
- •13. Plasmapheresis
- •14. Breastfeeding women
- •15. Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion
- •16. Unwilling or unable to be fully evaluated for all follow-up visits
研究者
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