JPRN-UMIN000018752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-CSF mediated spinal cord injury recovery induction trial(G-SPIRIT)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- 16years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
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 have unstable physical status 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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