ChiCTR2400080972 版本V1.0 版本创建时间2024/02/19 16:59:47 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400080972 

最近更新日期：

Date of Last Refreshed on：

2024-02-19 16:59:33 

注册时间：

Date of Registration：

2024-02-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

注射用GD-11治疗急性缺血性卒中III期临床试验——多中心、随机、双盲、平行、 安慰剂对照III期临床研究

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

注射用GD-11治疗急性缺血性卒中III期临床试验——多中心、随机、双盲、平行、 安慰剂对照III期临床研究

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

陈涛 

研究负责人：

王拥军 

Applicant：

Chen Tao 

Study leader：

Wang Yongjun 

申请注册联系人电话：

Applicant telephone：

+86 133 9097 7007

研究负责人电话：

Study leader's telephone：

+86 10 5997 8538

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

chentao@wangao.com.cn

研究负责人电子邮件：

Study leader's E-mail：

yongjunwang111@aliyun.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

江苏省海门经济技术开发区定海路688号

研究负责人通讯地址：

北京市丰台区南四环西路119号

Applicant address：

No.688 Dinghai Road, Haimen Economic and Technological Development Zone, Jiangsu Province, China

Study leader's address：

No. 119, South Fourth Ring West Road, Fengtai District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

江苏万高药业股份有限公司

Applicant's institution：

Jiangsu Vanguard Pharmaceutical Co., Ltd

研究负责人所在单位：

首都医科大学附属北京天坛医院

Affiliation of the Leader：

Beijing Tiantan Hospital, Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

YW2023-050-02

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京天坛医院医学伦理委员会

Name of the ethic committee：

IRB of Beijing Tiantan Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-01-23 00:00:00

伦理委员会联系人：

肖淑萍

Contact Name of the ethic committee：

Xiao Shuping

伦理委员会联系地址：

北京市丰台区南四环西路119号

Contact Address of the ethic committee：

No. 119, South Fourth Ring West Road, Fengtai District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 5997 8555

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

首都医科大学附属北京天坛医院

Primary sponsor：

Beijing Tiantan Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市丰台区南四环西路119号

Primary sponsor's address：

No. 119, South Fourth Ring West Road, Fengtai District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

南通市

Country：

China

Province：

Jiangsu Province

City：

Nantong

单位(医院)：

江苏万高药业股份有限公司

具体地址：

海门经济技术开发区定海路688号

Institution
hospital：

Jiangsu Vanguard Pharmaceutical Co., Ltd

Address：

No.688 Dinghai Road, Haimen Economic and Technological Development Zone

经费或物资来源：

自筹

Source(s) of funding：

Self-fiance

Target disease：

Acute ischemic stroke

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 III期临床试验 

Study phase：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价注射用GD-11治疗发病在48h以内的急性缺血性卒中患者的有效性和安全性  

Objectives of Study：

Evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

符合以下所有项目者，才能入组： 1.年龄≥18周岁且＜81周岁，男女不限； 2.此次发病后，美国国立研究院卒中量表评分:6≤NIHSS≤20分，且第5项上肢和第6项下肢评分之和≥2分； 3.发病在48 h以内（包含48小时）； 4.根据《中国各类主要脑血管病诊断要点2019》或《中国脑血管病临床管理指南（第2版）》等最新指南要求诊断为缺血性脑卒中，首次发病或上次发病后愈后良好（此次发病前mRS评分≤1分）患者； 5.获得患者或其法定代理人自愿签署经伦理委员会核准的知情同意书。

Inclusion criteria

Only those who meet all of the following items will be enrolled: 1. age ≥18 years and <81 years, male or female; 2. 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; 3. The onset of the disease is within 48 hours (including 48 hours); 4. 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); 5. Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.

排除标准：

筛选时符合以下项目之一者，不能入组： 1.头颅影像所见颅内出血性疾病：出血性卒中，硬膜外血肿，颅内血肿，脑室出血，蛛网膜下腔出血等；如仅为渗血，可根据研究者判断是否适合入组； 2.重度的意识障碍：NIHSS的1a意识水平的项目得分>1分； 3.此次发病后已应用或计划应用溶栓、取栓或介入治疗； 4.短暂性脑缺血发作（TIA）； 5.患者血压经控制后收缩压仍≥220mmHg或舒张压≥120mmHg； 6.既往诊断严重精神障碍患者以及痴呆患者； 7.已诊断有严重的活动性肝脏疾病，如急性肝炎、慢性活动性肝炎、肝硬化等；或ALT或AST>2.0×ULN； 8.已诊断有严重的活动性肾病、肾功能不全；或血清肌酐>1.5×ULN； 9.此次发病后已应用说明书中有神经保护作用的药物，如市售依达拉奉、依达拉奉右莰醇注射用浓溶液、尼莫地平、神经节苷脂、胞二磷胆碱、吡拉西坦、奥拉西坦、丁基苯肽、人尿激肽原酶（尤瑞克林），桂哌齐特、鼠神经生长因子、脑活素（脑蛋白水解物）、小牛血清去蛋白注射液、小牛血去蛋白提取物注射液等； 10.既往诊断并发恶性肿瘤且正在进行抗肿瘤治疗； 对入组后确诊恶性肿瘤的受试者，可根据研究者判断和受试者意愿是否继续参与研究； 11.既往诊断患有严重的全身性疾病，预计生存期<90天； 12.患者处于妊娠期，哺乳期以及患者/患者伴侣有妊娠可能并计划在试验期间妊娠； 13.既往已知对注射用GD-11及其辅料过敏的患者； 14.入组前4周内大手术史且研究者评估影响到神经功能评分或影响到90天生存期的； 15.随机前30天内参加过其他临床研究，或者正在参加其他临床研究； 研究者认为不适合参加本临床研究。

Exclusion criteria：

Those who met one of the following items at screening will not be eligible for enrollment: 1. 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; 2. severe impairment of consciousness: item score >1 on the 1a level of consciousness of the NIHSS; 3. thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode; 4. transient ischemic attack (TIA); 5. the patient's blood pressure remains ≥ 220 mmHg systolic or ≥ 120 mmHg diastolic after control; 6. patients with a previous diagnosis of severe mental disorders as well as patients with dementia; 7. patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0 x ULN; 8. patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine > 1.5 × ULN; 9. after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran camphenol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oracetam, butylphenyl peptide, human urokininogenin (eurycomelic acid), cinpirexit, 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. Calf serum deprotein injection, calf blood deprotein extract injection, etc; 10. 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; 11. previously diagnosed with a serious systemic disease with an expected survival of <90 days; 12. 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 13. patients with a previously known hypersensitivity to GD-11 for Injection and its excipients; 14. 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; 15. 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.

研究实施时间：

Study execute time：

从 From 2024-01-23 00:00:00至 To 2025-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-02-19 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

注射用GD-11试验组

样本量：

490

Group：

GD-11 for injection test group

Sample size：

干预措施：

注射用GD-11，冻干粉针，80mg/瓶，160mg/次 试验药物临用前，从规格为100ml生理盐水输液袋中，用无菌注射器抽取约15ml生理盐水注入试验药物冻干粉针瓶中，经振荡器或人工振动5min左右，完全溶解后用无菌注射器注回给药输液袋中，轻摇混匀，静脉滴注30min±10min。 第1次用药应在随机后尽快完成；第2次用药距离第1次用药开始时间不得少于6小时，但不超过12＋1h；后续每次用药时间间隔12±1h（以固定下来的给药时间为基线点计算且每次用药距离上次用药开始时间不得少于6小时）；连续治疗10天，共20次。

干预措施代码：

Intervention：

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.

Intervention code：

组别：

安慰剂对照组

样本量：

490

Group：

Placebo control group

Sample size：

干预措施：

注射用GD-11安慰剂，冻干粉针，80mg/瓶，160mg/次 试验药物临用前，从规格为100ml生理盐水输液袋中，用无菌注射器抽取约15ml生理盐水注入试验药物冻干粉针瓶中，经振荡器或人工振动5min左右，完全溶解后用无菌注射器注回给药输液袋中，轻摇混匀，静脉滴注30min±10min。 第1次用药应在随机后尽快完成；第2次用药距离第1次用药开始时间不得少于6小时，但不超过12＋1h；后续每次用药时间间隔12±1h（以固定下来的给药时间为基线点计算且每次用药距离上次用药开始时间不得少于6小时）；连续治疗10天，共20次。

干预措施代码：

Intervention：

Placebo, freeze-dried powder, 80mg, 160mg/dose Before the placebo 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.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都医科大学附属北京天坛医院 

单位级别：

三甲 

Institution
hospital：

Beijing Tiantan Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

治疗第90天mRS评分≤1分的受试者比例

指标类型：

主要指标

Outcome：

Proportion of subjects with mRS score ≤1 on 90th day of treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗第90天mRS评分的等级分析

指标类型：

次要指标

Outcome：

Grade analysis of mRS scores on the 90th day of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗第90天mRS评分≤2分的受试者比例

指标类型：

次要指标

Outcome：

Proportion of subjects with mRS score ≤2 on the 90th day of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗第10天或出院时NIHSS评分相比基线时变化

指标类型：

次要指标

Outcome：

Change in NIHSS score on the10th day of treatment or discharge compared to baseline

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗第10天或出院时、30天NIHSS评分为0-1或较基线减少≥4分的比例

指标类型：

次要指标

Outcome：

Percentage of patients with a NIHSS score of 0-1 or a reduction of ≥4 points from baseline on the 10th day of treatment or at discharge or at the 30th day

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗第90天日常生活活动能力量表Barthel Index评分≥95的比例

指标类型：

次要指标

Outcome：

The proportion of Barthel Index score ≥95 on the Activity of daily living scale on the 90th day of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组不良事件（AE）发生率

指标类型：

副作用指标

Outcome：

Adverse event (AE) rates in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组治疗相关的不良事件（TEAE）发生率

指标类型：

副作用指标

Outcome：

Treatment-related adverse events (TEAE) rates in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组重要不良事件发生情况

指标类型：

副作用指标

Outcome：

Occurrence of important adverse events in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组严重不良事件（SAE）发生情况

指标类型：

副作用指标

Outcome：

Occurrence of serious adverse events (SAEs) in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组可疑且非预期严重不良反应（SUSAR）发生情况

指标类型：

副作用指标

Outcome：

Occurrence of Suspected and Unexpected Serious Adverse Reactions (SUSAR) in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组实验室检查指标的变化

指标类型：

副作用指标

Outcome：

Changes in the indicators of laboratory tests in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组生命体征治疗前后变化（心率、血压、体温、呼吸）

指标类型：

副作用指标

Outcome：

Changes in vital signs of each group before and after treatment (heart rate, blood pressure, temperature, respiration)

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组全身体格检查治疗前后的变化

指标类型：

副作用指标

Outcome：

Changes in general physical examination before and after treatment in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组其它临床实验室检查异常（不限于血常规、血生化和尿常规）情况

指标类型：

副作用指标

Outcome：

Abnormalities of other clinical laboratory tests (not limited to routine blood, blood biochemistry and urine routine) in each group

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

因不良事件原因导致停药情况

指标类型：

副作用指标

Outcome：

Discontinuation due to adverse events

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

因任何其他非不良事件原因导致停药情况

指标类型：

副作用指标

Outcome：

Discontinuation due to any other non-adverse event reason

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验为采用多中心、随机、双盲、安慰剂平行对照试验设计。受试者按照1:1比例进行随机分配，随机数字表利用SAS软件产生。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This trial is designed as a multicenter, randomized, double-blind, placebo-parallel controlled trial using a multicenter, randomized, double-blind, placebo-parallel controlled trial design. Subjects are randomly assigned in a 1:1 ratio and random number tables are generated using SAS software.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲

Blinding：

Double-blinded

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

/

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

/

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本试验将采用电子数据采集系统（EDC）进行数据的收集和管理。数据管理过程应符合《药物临床试验质量管理规范》（GCP）及相应数据管理法规要求，遵照数据管理部门的标准操作规程（SOP），确保临床试验数据的真实、准确、完整、可靠和可溯源性（EDC系统将记录所有稽查轨迹）。 本试验数据录入为直接录入EDC，研究者或经研究者授权临床研究协调（CRC）根据受试者的原始资料信息，准确、及时、完整、规范、真实地通过EDC系统填写受试者信息，不得随意更改。eCRF中所有项目均需填写，不得空项或遗漏。如有需要，eCRF进行数据更正时，需按照系统提示，填写数据修改的原因。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This trial will use an electronic data collection system (EDC) for data collection and management. The data management process shall comply with the Good Clinical Practice (GCP) for Drug Clinical Trials and the corresponding data management regulatory requirements, and follow the standard operating procedures (SOPs) of the data management department to ensure the truthfulness, accuracy, completeness, reliability, and traceability of the clinical trial data (all audit trails will be recorded by the EDC system). The data entry of this trial is directly into the EDC, and the investigator or the clinical research coordination (CRC) authorized by the investigator fills in the subject information through the EDC system accurately, timely, complete, standardized, and truthful based on the subject's original data information, and shall not be altered arbitrarily. eCRF is required to be filled in for all items, and shall not be blanked out or omitted. If there is a need for data correction in eCRF, the reason for data modification should be filled in according to the system prompts.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-02-19 16:59:33