NCT02363361Unknown2 期
Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)
Professor Mikael Svensson, MD PhD0 个研究点目标入组 10 人开始时间: 2018年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 主要终点
- Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19
研究概览
简要总结
This is a phase II, single center, open-label, non randomized clinical study to assess the uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients. The aim is to determine if Imatinib reaches sufficient blood levels when given to patients with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety and tolerability of this drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-80 years
- •Clinical signs of cervical spinal cord injury due to trauma.
- •In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
- •Patient that is conscious and oriented x 4 (regarding date/time, localisation, situation and personal details), with higher level of consciousness, i.e. Glasgow Coma Scale > 14, and is assessed to be competent to give informed consent.
排除标准
- •Diabetes (type I and II)
- •Ongoing cancer treatment
- •Known allergy to study drug Imatinib or its excipients
- •On current therapy with drugs which may interfere with Imatinib, (e.g. paracetamol, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidon, Hypericum perforatum).
- •Female subjects lactating or with positive pregnancy test
- •Known liver or kidney disease
- •Any relevant surgical or medical condition which in the opinion of the investigator may interfere with the conduct of the study or the scientific results. This includes hemorrhagic conditions.
研究组 & 干预措施
Imatinib
Experimental
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
干预措施: Imatinib (Drug)
结局指标
主要结局
Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19
时间窗: Day 1-3, 7, 10, 14, 16, 19
次要结局
- Adverse events(Day 1-19)
研究者
Professor Mikael Svensson, MD PhD
professor, MD, PhD
Karolinska University Hospital
相似试验
招募中
1 期
Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical CarcinomaCervical CarcinomaNCT06241235Suzhou Zelgen Biopharmaceuticals Co.,Ltd48
Unknown
2 期
Efficacy and Safety of the PET Imaging Agent [18F]NAV4694 in Subjects With Probable Alzheimer's DiseaseAlzheimer DiseaseNCT01680588Navidea Biopharmaceuticals70
Unknown
2 期
PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell LymphomaNK/T-cell LymphomaNCT03701022Peking University61
Unknown
2 期
SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell LymphomaExtranodal NK/T-cell Lymphoma, Nasal TypeNCT03363555Jiangsu HengRui Medicine Co., Ltd.97
招募中
2 期
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)Relapsed or Refractory Peripheral T-cell LymphomaNCT05833724Great Novel Therapeutics Biotech & Medicals Corporation33