NL-OMON48885已完成2 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
- 2 期
- 状态
- 已完成
- 发起方
- Adrenomed AG
- 入组人数
- 50
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
- 年龄范围
- 18 至 64（—）
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
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 *L
- •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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