JPRN-jRCT2091220217已完成3 期
Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury - G-SPIRIT
Coordinating Committee0 个研究点目标入组 88 人开始时间: 2015年7月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
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
- >= 16age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •(1) AIS Grade is B or C at screening
- •(2) AIS Grade is B or C at re-assessment of neurological status 48 hours (plus-minus 4 hours) after the injury
- •(3) Neurological level of injury is between C4 and C7
- •(4) Age betweem 16-85
- •(5) Patients who give informed consent to participate in the present trial
- •(6) Patients who can visit 3 months, 6 months, and 12 months after administration
排除标准
- •(1) Allergy to filgrastim.
- •(2) Hematologic malignancy or its previous history
- •(3) Malignant disease under treatment
- •(4) invasive treatment for myocardial infarction or angina pectoris within 6 months
- •(5) previous history of rombosis
- •(6) splenomegaly.
- •(7) consciousness disorder.
- •(8) Patients who are pregnant women, are willing to become pregnant in study period or are lactation.
- •(9) Neurological disorder which can affect neurological evaluation in the present trial
- •(10) Patients who receive filgrastim or methylprednisolone sodium succinate after the injury
- •(11) Patients who are expected to have rapid worsening of symptoms during the trial period
- •(12) Patients with serious complications
- •(13) Patients who can not start the rehabilitation in early by complications
- •(14) Patients with advanced dementia or mental illness
- •(15) Patients who can not start the rehabilitation in early by multiple trauma or organ damage
- •(16) Patients who have fracture of extremities, the spine, or the other parts which can affect neurological evaluation in the present trial
- •(17) Patients who are participating in other trials, or received other study drugs within 12 weeks
- •(18) In addition, the patient whom investigator judged to be unsuitable as a patient.
研究者
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