ChiCTR2600124690 版本V1.0 版本创建时间2026/05/15 14:21:36 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：

 ChiCTR2600124690 

最近更新日期：

Date of Last Refreshed on：

 2026-05-15 14:21:22 

注册时间：

Date of Registration：

 2026-05-15 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

探索恩那度司他片在中国健康研究参与者中预防急性高原反应安全性、有效性的临床研究

Public title：

A Clinical Study to Explore the Safety and Efficacy of Enarsentan Tablets in Preventing Acute Mountain Sickness in Healthy Chinese Research Participants

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探索恩那度司他片在中国健康研究参与者中预防急性高原反应安全性、有效性的临床研究

Scientific title：

A Clinical Study to Explore the Safety and Efficacy of Enarsentan Tablets in Preventing Acute Mountain Sickness in Healthy Chinese Research Participants

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：

曾洁萍 

研究负责人：

曾洁萍 

Applicant：

Zeng Jieping 

Study leader：

Zeng Jieping 

申请注册联系人电话：

Applicant telephone：

 +86 15928914195

研究负责人电话：

Study leader's
telephone：

+86 15928914195

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：

 zengjieping2000@126.com

研究负责人电子邮件：

Study leader's E-mail：

 zengjieping2000@126.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：

四川省成都市金牛区十二桥路37号

研究负责人通讯地址：

四川省成都市金牛区十二桥路37号

Applicant address：

No. 37, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province

Study leader's address：

No. 37, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province

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：

成都中医药大学附属医院

Applicant's institution：

Affiliated Hospital of Chengdu University of TCM

研究负责人所在单位：

成都中医药大学附属医院

Affiliation of the Leader：

Hospital of Chengdu University of Traditional Chinese Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025KL-258

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：

成都中医药大学附属医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-04 00:00:00

伦理委员会联系人：

王艳桥

Contact Name of the ethic committee：

Wang Yanqiao

伦理委员会联系地址：

四川省成都市金牛区十二桥路37号

Contact Address of the ethic committee：

No. 37, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 28 87783142

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 13880544512@163.com

研究实施负责（组长）单位：

成都中医药大学附属医院

Primary sponsor：

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

四川省成都市金牛区十二桥路37号

Primary sponsor's address：

No. 37, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都中医药大学附属医院

具体地址：

四川省成都市金牛区十二桥路37号

Institution
hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Address：

No. 37, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province

经费或物资来源：

深圳信立泰药业股份有限公司

Source(s) of funding：

Shenzhen Salubris Pharmaceuticals Co, Ltd

研究疾病：

急性高原反应  

Target disease：

Acute Mountain Sickness

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.主要目的 评价恩那度司他片在中国健康研究参与者中预防急性高原反应的安全性。 2.次要目的 评价恩那度司他片在中国健康研究参与者中预防急性高原反应的药代动力学及药效动力学特征； 初步探索恩那度司他片在中国健康研究参与者中预防急性高原反应的有效性。  

Objectives of Study：

1. Primary Objective To evaluate the safety of enadustat tablets in preventing acute high-altitude sickness in healthy participants in China. 2. Secondary Objectives To evaluate the pharmacokinetic and pharmacodynamic characteristics of enadustat tablets in preventing acute high-altitude sickness in healthy participants in China; To preliminarily explore the efficacy of enadustat tablets in preventing acute high-altitude sickness in healthy participants in China.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.对本研究已充分了解并自愿签署书面知情同意书，能够遵守知情同意书中所列的要求和限制； 2.年龄18~65周岁（包含18周岁和65周岁）的男性或女性； 3.筛选时男性体重>=50?kg，女性体重>=45?kg，且身体质量指数（BMI）在19.0~30.0?kg/m^2之间（包括19.0?kg/m^2和30.0?kg/m^2）； 4.主要居住地为低海拔地区（海拔750米或以下）； 5.筛选时各项检查（包括体格检查、生命体征检查、血常规、尿常规、血生化、凝血功能、C反应蛋白、12导联心电图、胸部正位片等）结果无异常或有轻微异常但经研究者判断无临床意义； 6.研究参与者或其伴侣在签署知情同意书至试验用药品末次给药后3个月内无妊娠计划，自愿采取有效避孕措施（详见附录1，研究期间禁止使用避孕药）避免使自己或伴侣怀孕，且研究参与者不因生殖或辅助生殖目的捐献精子或卵子（卵细胞、卵母细胞）。

Inclusion criteria

1. Fully understood this study and voluntarily signed the written informed consent form, and are able to comply with the requirements and restrictions listed in the informed consent form; 2. Male or female aged 18 to 65 years (including 18 and 65 years); 3. At screening, males weigh >= 50 kg, females weigh >= 45 kg, and body mass index (BMI) is between 19.0 and 30.0 kg/m^2 (including 19.0 kg/m^2 and 30.0 kg/m^2); 4. The primary residence is in a low-altitude area (750 meters or below); 5. At the time of screening, all examinations (including physical examination, vital signs check, blood routine, urine routine, blood biochemistry, coagulation function, C-reactive protein, 12-lead ECG, chest radiograph, etc.) show no abnormalities or only minor abnormalities judged by the investigator to be clinically insignificant; 6. The study participant or their partner has no pregnancy plans from the signing of the informed consent to three months after the last administration of the investigational drug, voluntarily uses effective contraception (see Appendix 1; the use of contraceptive pills is prohibited during the study) to avoid pregnancy for themselves or their partner, and the study participant does not donate sperm or eggs (oocytes, oocyte cells) for reproductive or assisted reproductive purposes.

排除标准：

1.妊娠、哺乳期妇女，或具有生育能力的女性（生育能力评判标准详见附录1）妊娠筛查结果呈阳性； 2.筛选前2周有临床意义的急性药物或食物过敏反应史，或过敏体质（如对两种或以上药物、食物或花粉过敏），或有变态反应性病史（如哮喘、荨麻疹、湿疹性皮炎等），或经研究者判断可能或明确对试验药物（包括类似药物或对照药物）及其中任何辅料过敏、存在超敏反应或有临床意义的显著反应； 3.筛选及首次给药前，任意一次LLSS自我总评分>=2分； 4.筛选前2年内到达过高海拔地区（2500米以上）或既往前往高海拔地区多于一次； 5.有重度高原反应史或重度高原反应家族史； 6.患有以下疾病或既往病史： (1)患有心血管疾病（如心律失常、心衰、肺动脉高压）、脑血管疾病（如脑出血、脑梗死）或既往病史的研究参与者； (2)患有血栓栓塞（如肺栓塞、深静脉血栓形成）或既往病史的研究参与者； (3)患有哮喘病、肺结核、慢性支气管炎、肺气肿等呼吸系统疾病或既往病史的研究参与者； (4)患神经、精神系统急慢性疾病（如不由高原缺氧所致的疲劳综合征、睡眠障碍、重度焦虑、重度抑郁等）且未治愈者； (5)患有年龄相关的黄斑变性、增生性脉络膜或视网膜病变等眼底病变或既往病史的研究参与者； (6)首次给药前2周内发生感冒、发烧或呼吸道感染（如病毒感染、细菌感染等）等疾病的研究参与者； (7)既往经常发生原发性头痛者（如偏头痛、紧张型头痛或者丛集性头痛等）或者发生继发性头痛者（如感染或者血管性疾病造成的头痛等）； (8)筛选前5年内，有严重的晕动症，可能会显著影响研究评估者。 7.筛选时收缩压>140?mmHg和/或舒张压>90?mmHg； 8.筛选时外周血氧饱和度（SpO2）<95%； 9.筛选时男性Hb>165?g/L，女性Hb>140?g/L； 10.筛选时转铁蛋白饱和度（TSAT）<20%； 11.筛选时凝血功能检查研究者判定为异常有临床意义； 12.筛选时乙肝表面抗原、丙肝抗体、HIV抗体和梅毒螺旋体抗体检查任一结果呈阳性； 13.首次给药前使用了以下任何一种食物、药物或治疗： (1)首次给药前1周内使用过任何处方药、中草药、非处方药和食物补充剂（包括维生素、保健食品等）； (2)首次给药前72小时内服用过含酒精、咖啡因或黄嘌呤的食物或饮料。 14.毒品或药物滥用、酗酒或嗜烟： (1)有吸毒或药物滥用史，或筛选时药物滥用筛查结果呈阳性； (2)筛选前3个月平均每周饮酒量大于14个单位（1单位≈17.7?mL乙醇，即1单位≈酒精量5%的啤酒360?mL，或酒精量40%的白酒45?mL，或酒精量12%的葡萄酒150?mL），或筛选时酒精呼气测试结果呈阳性，或不能在研究期间完全停止食用任何含有酒精成分的食物或饮品； (3)筛选前3个月平均每日吸烟量多于5支，或不能在研究期间完全停止使用任何烟草类产品； (4)筛选前3个月内饮用过量（8杯/日以上，1杯=250mL）茶、咖啡或含咖啡因的饮料/食物（如巧克力）者。 15.筛选前3个月内献血（包括成分献血）或失血>=400?mL，筛选前1个月内献血（包括成分献血）或失血>=200?mL或接受过输血，或计划在研究期间或研究结束后1个月内献血或血液成分； 16.有晕针史、晕血史或不能耐受静脉穿刺者（问询）； 17.筛选前3个月内接种过灭活疫苗、活疫苗、减毒活疫苗或任何活病毒成分的疫苗，或计划在研究期间或研究结束后3个月内接种上述疫苗； 18.筛选前3个月内经历过严重创伤或接受过重大外科手术（如需全身麻醉），或计划在研究期间或研究结束后3个月内进行手术（局部麻醉手术除外）； 19.筛选前3个月内参加过或正在参加任何干预性临床研究（包括试验性药物或疫苗，以及本试验药物的其他临床研究）并接受过研究用药物； 20.研究者判断存在其他的有临床意义或可能妨碍研究参与者完成此研究的疾病或病史（包括各系统如：呼吸、心血管、消化、泌尿生殖、血液、内分泌、神经、精神以及恶性肿瘤等），或其他可能显著改变药物吸收、代谢或清除的疾病或病史（如胃肠手术、肾脏手术或胆囊切除术等判断可能影响药物体内处置过程的手术史），或感染性疾病（如细菌感染、结核感染等）； 研究者判断的其他不适合参加该研究或因自身原因退出的研究参与者。

Exclusion criteria：

1. Pregnant or lactating women, or women of childbearing potential (criteria for assessing childbearing potential are detailed in Appendix 1) with a positive pregnancy screening result; 2. History of clinically significant acute drug or food allergic reactions within 2 weeks prior to screening, or allergic constitution (such as allergy to two or more drugs, foods, or pollens), or history of atopic disease (such as asthma, urticaria, atopic dermatitis, etc.), or judged by the investigator to possibly or clearly have an allergy, hypersensitivity, or clinically significant reaction to the investigational drug (including similar drugs or control drugs) or any of its excipients; 3. At any time before screening and first dosing, LLSS self-reported total score >= 2 points; 4. Reached a high-altitude area (above 2,500 meters) within 2 years prior to screening or visited high-altitude areas more than once in the past; 5. History of severe high-altitude illness or family history of severe high-altitude illness. 6. Participants with the following diseases or medical history: (1) Participants with cardiovascular diseases (such as arrhythmia, heart failure, pulmonary hypertension), cerebrovascular diseases (such as cerebral hemorrhage, cerebral infarction), or a history of these conditions; (2) Participants with thromboembolism (such as pulmonary embolism, deep vein thrombosis) or a history of these conditions; (3) Participants with respiratory diseases such as asthma, pulmonary tuberculosis, chronic bronchitis, emphysema, or a history of these conditions; (4) Participants with acute or chronic neurological or psychiatric disorders (such as fatigue syndrome not caused by high-altitude hypoxia, sleep disorders, severe anxiety, severe depression, etc.) that have not been cured; (5) Participants with age-related macular degeneration, proliferative choroidal or retinal diseases, or a history of these ocular lesions; (6) Participants who have had a cold, fever, or respiratory infection (such as viral or bacterial infection) within 2 weeks before the first dose; (7) Participants who frequently suffered from primary headaches (such as migraine, tension-type headache, or cluster headache) or secondary headaches (such as headaches caused by infection or vascular disease); (8) Participants who have had severe motion sickness in the past 5 years, which may significantly affect study assessments. 7. Systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg at screening; 8. Peripheral oxygen saturation (SpO2) <95% at screening; 9. Hemoglobin (Hb) >165 g/L for men, >140 g/L for women at screening; 10. Transferrin saturation (TSAT) <20% at screening. 11. Abnormal coagulation function judged by the investigator during screening that is clinically significant; 12. Any of the following test results during screening are positive: hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody; 13. Using any of the following foods, drugs, or treatments before the first dose: (1) Use of any prescription drugs, Chinese herbal medicine, over-the-counter drugs, or dietary supplements (including vitamins, health products, etc.) within 1 week before the first dose; (2) Consumption of foods or drinks containing alcohol, caffeine, or xanthine within 72 hours before the first dose. 14. Drug or substance abuse, alcohol abuse, or smoking: (1) History of drug or substance abuse, or positive drug abuse screening result during screening; (2) Average weekly alcohol consumption greater than 14 units within 3 months before screening (1 unit ≈ 17.7 mL of ethanol, i.e., 1 unit ≈ 360 mL of beer with 5% alcohol, or 45 mL of spirits with 40% alcohol, or 150 mL of wine with 12% alcohol), or a positive breath alcohol test during screening, or inability to completely abstain from any foods or drinks containing alcohol during the study; (3) Average daily smoking of more than 5 cigarettes within 3 months before screening, or inability to completely stop using any tobacco products during the study; (4) Excessive consumption of tea, coffee, or caffeine-containing foods/drinks (e.g., chocolate) within 3 months before screening (more than 8 cups/day, 1 cup = 250 mL). 15. Donated blood (including component blood donation) or experienced blood loss >=400 mL within the 3 months prior to screening, donated blood (including component blood donation) or experienced blood loss >=200 mL, or received a blood transfusion within 1 month prior to screening, or plan to donate blood or blood components during the study period or within 1 month after the study ends; 16. History of fainting during injections, history of fainting at the sight of blood, or inability to tolerate venipuncture (based on inquiry); 17. Received inactivated vaccines, live vaccines, attenuated live vaccines, or any live-virus component vaccines within 3 months prior to screening, or plan to receive such vaccines during the study period or within 3 months after the study ends; 18. Experienced severe trauma or undergone major surgery (requiring general anesthesia) within 3 months prior to screening, or plan to undergo surgery (excluding procedures under local anesthesia) during the study period or within 3 months after the study ends. 19. Participated in or are currently participating in any interventional clinical study (including investigational drugs or vaccines, as well as other clinical studies of the study drug) within the past 3 months and received study medication; 20. The investigator judges that there are other clinically significant diseases or medical histories that may hinder the participant from completing this study (including systems such as respiratory, cardiovascular, digestive, genitourinary, hematologic, endocrine, neurological, psychiatric, and malignant tumors), or other diseases or histories that may significantly alter drug absorption, metabolism, or clearance (such as history of gastrointestinal surgery, kidney surgery, or cholecystectomy that may affect drug disposition), or infectious diseases (such as bacterial infection, tuberculosis infection, etc.); other participants deemed by the investigator as unsuitable for participating in this study or who withdraw for personal reasons.

研究实施时间：

Study execute time：

从 From 2025-12-12 00:00:00至 To 2026-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-12 00:00:00 至 To 2026-01-04 00:00:00

干预措施：

Interventions：

组别：

给药组

样本量：

 16

Group：

Treatment Group

Sample size：

干预措施：

恩那度司他

干预措施代码：

Intervention：

Enarsentan

Intervention code：

组别：

对照组

样本量：

 16

Group：

Control Group

Sample size：

干预措施：

恩那度司他模拟剂

干预措施代码：

Intervention：

Enarsentan Placebo

Intervention code：

组别：

哨兵组

样本量：

 6

Group：

Sentinel Group

Sample size：

干预措施：

恩那度司他片

干预措施代码：

Intervention：

Enarsentan

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 成都中医药大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 稻城县人民医院 

单位级别：

 二级甲等 

Institution
hospital：

Daocheng County People's Hospital

Level of the institution：

Secondary A

测量指标：

Outcomes：

指标中文名：

AMS发病率

指标类型：

主要指标

Outcome：

Incidence rate of AMS

Type：

Primary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

LLSS评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

Diagnosis based on LLSS score

指标中文名：

LLSS评分较基线变化水平

指标类型：

次要指标

Outcome：

The change level of LLSS score compared with baseline

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18各访视

测量方法：

通过LLSS评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

Diagnosis based on the LLSS score

指标中文名：

LLSS评分较D15抵达高原后6h下降的百分比

指标类型：

次要指标

Outcome：

Percentage reduction in LLSS score at 6 h post-high-altitude arrival relative to Day 15

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

LLSS评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

Diagnosis based on the LLSS score

指标中文名：

GJB 1098-91评分较基线变化水平

指标类型：

次要指标

Outcome：

The change level of GJB 1098-91 score compared with baseline

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

急性高原反应的诊断和处理原则（GJB?1098-91）评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

diagnosis based on the score of Diagnostic and Treatment Principles for Acute Mountain Sickness (GJB 1098-91)

指标中文名：

AMS临床功能评分

指标类型：

次要指标

Outcome：

AMS clinical function score

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

急性高原反应的诊断和处理原则（GJB?1098-91）评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

diagnosis based on the score of Diagnostic and Treatment Principles for Acute Mountain Sickness (GJB 1098-91)

指标中文名：

中重度AMS、HAPE和HACE的发生率

指标类型：

次要指标

Outcome：

Incidence of moderate to severe AMS, HAPE, and HACE

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

通过LLSS评分诊断、急性高原反应的诊断和处理原则（GJB?1098-91）评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

Diagnosis based on the LLSS score, and diagnosis based on the score of Diagnostic and Treatment Principles for Acute Mountain Sickness (GJB 1098-91)

指标中文名：

接受补救治疗的研究参与者的累计发生率

指标类型：

次要指标

Outcome：

Cumulative incidence of participants receiving rescue therapy

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

例数统计

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

Number of cases

指标中文名：

AMS发生时间

指标类型：

次要指标

Outcome：

Time to onset of AMS

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

时间记录

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

Time recording

指标中文名：

AMS发病率

指标类型：

次要指标

Outcome：

MS incidence rate

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

急性高原反应的诊断和处理原则（GJB?1098-91）评分诊断

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

diagnosis based on the score of Diagnostic and Treatment Principles for Acute Mountain Sickness (GJB 1098-91)

指标中文名：

SpO2较基线变化

指标类型：

次要指标

Outcome：

Change in SpO2 from baseline

Type：

Secondary indicator

测量时间点：

D15抵达高原后~D18

测量方法：

SpO?

Measure time point of outcome：

From Day 15 after arriving at the plateau to Day 18

Measure method：

SpO?

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

静脉血

组织：

Sample Name：

venous blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

除哨兵组外的其他研究参与者采用随机表，进行研究参与者随机和药物发放，随机分配表由统计师应用SAS（9.4或更高版本）按1:1的比例按照区组随机的方法产生。

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

Apart from the sentinel group, other study participants will be randomized and assigned to receive the study drug using a randomization table. The randomization table will be generated by a statistician using SAS (version 9.4 or higher) according to a 1:1 allocation ratio through block randomization method.

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：

对研究者和参试者设盲

Blinding：

Blinding for researchers and participants

是否共享原始数据：

IPD sharing

是Yes

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）：

邮件联系研究者

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

Contact the researcher by email

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：

eCRF

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

eCRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-15 14:21:22