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 个研究点开始时间: 待定最近更新: 2020年9月18日

试验速览

暂无简介。

•(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

•(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.

Transition of motor paralysis

未报告次要终点

发起方

Coordinating Committee