NCT04475224Unknown3 期
A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration
研究概览
简要总结
This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old
- •Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained
排除标准
- •The injury site is C1-C2 or C2-C3
- •The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary
- •It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury
- •A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI
- •Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury
- •High dose steroid therapy administered for spinal cord injury
- •Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy
- •History of malignant tumor
- •Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration
- •Drug allergies to drugs that will be (or may be) used
- •Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass
- •Problems with the subject's ability to give informed consent in person
- •The subject is breastfeeding or possibly pregnant
- •The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator
- •It is inappropriate for the subject to be included in the study, in the judgement of the investigator
研究组 & 干预措施
Open-label
Other
干预措施: KP-100IT (Drug)
结局指标
主要结局
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration
时间窗: 24 weeks
次要结局
- Time course of AIS classification(up to 24weeks)
- Time course of ASIA motor score (total/ upper extremity / lower upper extremity)(up to 24weeks)
- Time course of ASIA sensory score(up to 24weeks)
- Time course of neurological level of injury(up to 24weeks)
- Evaluation of adverse events(up to 24weeks)
- Time course of modified Frankel classification(up to 24weeks)
- Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration(12 weeks and 24 weeks)
- Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration(up to 24weeks)
研究者
研究点 (5)
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