Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 980
- 试验地点
- 2
- 主要终点
- Proportion of subjects with mRS score ≤1 on 90th day of treatment
研究概览
简要总结
Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment.
详细描述
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was used. Subjects were randomly assigned in a 1:1 ratio to the experimental group (GD-11 for injection treatment group) and the control group (GD-11 for injection placebo group). Randomization stratification factors included onset time (≤24 hours, >24 hours) and center.Continuous treatment was performed for 10 days (20 times), followed up to 90 days after the first administration.
The trial was divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.
Screening/baseline phase: Subjects entered the screening/baseline phase after signing the informed consent for screening examinations.
Treatment phase: Eligible subjects were randomly assigned in a 1:1 ratio to receive GD-11 for injection or placebo for injection for 10 days (20 times). During the treatment, protocol-required examinations were performed and safety was evaluated.
Follow-up phase: Subjects who completed the treatment entered the follow-up phase and were followed up to 90 days after the first administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only those who meet all of the following items will be enrolled:
- •age ≥18 years and <81 years, male or female;
- •National Institutes of Health Stroke Scale (NIHSS) score: 6 ≤ NIHSS ≤ 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores ≥ 2 after the onset of this event;
- •The onset of the disease is within 48 hours (including 48 hours);
- •Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as "Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019" or "Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition)", and who have a good healing after the first onset or the last onset (mRS score ≤1 before this onset);
- •Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.
排除标准
- •Those who met one of the following items at screening will not be eligible for enrollment:
- •intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, the suitability for enrollment may be based on the investigator's judgment;
- •severe impairment of consciousness: item score >1 on the 1a level of consciousness of the NIHSS;
- •thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode;
- •transient ischemic attack (TIA);
- •the patient's blood pressure remains ≥ 220 mmHg systolic or ≥ 120 mmHg diastolic after control;
- •patients with a previous diagnosis of severe mental disorders as well as patients with dementia;
- •patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT (Alanine amino Transferase) or AST (Aspartate amino Transferase) > 2.0 x ULN (Upper Limit of Normal Value);
- •patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine > 1.5 × ULN;
- •after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran edaravone/(+)-2-Decanol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oxiracetam, butylphenyl peptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, murine nerve growth factor, cerebral vivax (hydrolysate of cerebral proteins), calf's blood deprivation of protein injection, calf's blood deprivation of protein extract injection and so on.
- •previously diagnosed with concurrent malignant tumors and undergoing anti-tumor therapy; for subjects diagnosed with malignant tumors after enrollment, continued participation in the study may be based on the investigator's judgment and the subject's wishes;
- •previously diagnosed with a serious systemic disease with an expected survival of <90 days;
- •the patient is pregnant, breastfeeding and the patient/patient's partner has the potential for pregnancy and plans to become pregnant during the trial period
- •patients with a previously known hypersensitivity to GD-11 for Injection and its excipients;
- •history of major surgery within 4 weeks prior to enrollment that in the investigator's assessment affects neurologic function scores or affects 90-day survival;
- •participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study; Not considered by the investigator to be suitable for participation in this clinical study.
研究组 & 干预措施
GD-11 for injection test group
GD-11 for injection, freeze-dried powder, 80mg, 160mg/dose Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml saline into the test drug, by the oscillator or artificial vibration for about 5min, completely dissolved and then injected back to the administration of the infusion bag with a sterile syringe, gently shaking and mixing, and then intravenously titrated for 30min ± 10min.
The first dose should be completed as soon as possible after randomization; the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h; each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose); 10 consecutive days of treatment, a total of 20 times.
干预措施: GD-11 for injection test group (Drug)
Placebo control group
Placebo, freeze-dried powder, 80mg, 160mg/dose Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml saline into the test drug, by the oscillator or artificial vibration for about 5min, completely dissolved and then injected back to the administration of the infusion bag with a sterile syringe, gently shaking and mixing, and then intravenously titrated for 30min ± 10min.
The first dose should be completed as soon as possible after randomization; the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h; each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose); 10 consecutive days of treatment, a total of 20 times.
干预措施: Placebo control group (Drug)
结局指标
主要结局
Proportion of subjects with mRS score ≤1 on 90th day of treatment
时间窗: on 90th day of treatment
Proportion of subjects with mRS score ≤1 on 90th day of treatment
次要结局
未报告次要终点
研究者
Yongjun Wang
Chief Physician
Beijing Tiantan Hospital