ChiCTR2500099529 版本V1.1 版本创建时间2025/04/01 18:07:41 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：

ChiCTR2500099529 

最近更新日期：

Date of Last Refreshed on：

2025-03-25 14:48:18 

注册时间：

Date of Registration：

2025-03-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项开放标签、单臂、单中心评估ENC1018胶囊在中重度活动性溃疡性结肠炎（UC）患者的安全性、药代动力学和初步有效性研究

Public title：

An open-label, single-arm, single-center study evaluating the safety, pharmacokinetics, and preliminary efficacy of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项开放标签、单臂、单中心评估ENC1018胶囊在中重度活动性溃疡性结肠炎（UC）患者的安全性、药代动力学和初步有效性研究

Scientific title：

An open-label, single-arm, single-center study evaluating the safety, pharmacokinetics, and preliminary efficacy of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC)

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：

石宇星 

研究负责人：

王新 

Applicant：

YuxingShi 

Study leader：

XinWang 

申请注册联系人电话：

Applicant telephone：

+86 21 5082 1573

研究负责人电话：

Study leader's telephone：

+86 29 8477 7551

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：

yuxing.shi@ennovabio.com

研究负责人电子邮件：

Study leader's E-mail：

wangx@fmmu.edu.cn

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：

上海市浦东新区金湘路861号A栋7层

研究负责人通讯地址：

陕西省西安市灞桥区新寺路569号

Applicant address：

7 Floor, Building A, 861 Jinxiang Road, Pudong District, Shanghai

Study leader's address：

569 Xinsi Road, Baqiao District, Xian, Shanxi 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：

上海轶诺药业有限公司

Applicant's institution：

Shanghai EnnovaBio Pharmaceuticals Co., Ltd

研究负责人所在单位：

第四军医大学唐都医院

Affiliation of the Leader：

Tangdu Hospital, Fourth Military 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：

第202411-06号

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：

第四军医大学唐都医院医学伦理委员会

Name of the ethic committee：

IEC of Institution for National Drug Clinical Trials, Tangdu Hospital, Fourth Military Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-11-27 00:00:00

伦理委员会联系人：

李诗草

Contact Name of the ethic committee：

ShicaoLi

伦理委员会联系地址：

陕西省西安市灞桥区新寺路569号

Contact Address of the ethic committee：

569 Xinsi Road, Baqiao District, Xian, Shanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 29 8471 7761

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：

第四军医大学唐都医院

Primary sponsor：

Tangdu Hospital, Fourth Military Medical University

研究实施负责（组长）单位地址：

陕西省西安市灞桥区新寺路569号

Primary sponsor's address：

569 Xinsi Road, Baqiao District, Xian, Shanxi 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)：

陕西

市(区县)：

Country：

China

Province：

Shanxi

City：

单位(医院)：

第四军医大学唐都医院

具体地址：

陕西省西安市灞桥区新寺路569号

Institution
hospital：

Tangdu Hospital, Fourth Military Medical University

Address：

569 Xinsi Road, Baqiao District, Xian, Shanxi Province

经费或物资来源：

上海轶诺药业有限公司

Source(s) of funding：

Shanghai EnnovaBio Pharmaceuticals Co., Ltd

Target disease：

Ulcerative Colitis

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的： ? 评价ENC1018在中重度活动性溃疡性结肠炎（UC）患者中的安全性和耐受性； ? 评价ENC1018、Tofacitinib和Berberrubine在中重度活动性溃疡性结肠炎（UC）患者中的药代动力学特征。 次要目的： ? 初步探索ENC1018在中重度活动性溃疡性结肠炎（UC）患者的有效性。  

Objectives of Study：

Primary objectives: ? To evaluate the safety and tolerability of ENC1018 in patients with moderate-to-severe active ulcerative colitis (UC); ? To evaluate the pharmacokinetics of ENC1018, Tofacitinib, and Berberrubine in patients with moderate-to-severe active ulcerative colitis (UC). Secondary purpose: ? To explore the efficacy of ENC1018 in patients with moderate-to-severe active ulcerative colitis (UC).

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. 年龄在18至75岁之间，男性或女性。 2. 在筛查前确诊溃疡性结肠炎至少3个月，该诊断必须通过内窥镜或放射学检查和组织学检查确认。 3. 患有中度至重度活动性溃疡性结肠炎，定义为改良的Mayo评分≥6分。 4. 由研究者判断对至少一种常规疗法（氨基水杨酸类、皮质类固醇或免疫调节剂）或生物制剂（抗TNF、抗α4β7整合素或抗IL-12/23等抗体药物）疗效不佳或不耐受。 5. 如果受试者正在口服氨基水杨酸类药物或口服糖皮质激素，则其剂量必须在入组前至少2周及研究期间保持稳定。 6. 自愿签署知情同意书且愿意遵守研究流程、依照方案规定完成试验。

Inclusion criteria

1. Aged between 18 and 75 years, male or female. 2. Ulcerative colitis has been diagnosed at least 3 months before screening, and the diagnosis must be confirmed by endoscopy or radiology and histology. 3. Have moderate to severe active ulcerative colitis, defined as a modified Mayo score ≥6. 4. Poor response or intolerance to at least one conventional therapy (aminosalicylic acids, corticosteroids, or immunomodulators) or biologics (anti-TNF, anti-α4β7 integrin, or anti-IL-12/23 antibody drugs) as determined by the investigator. 5. If subjects are taking oral aminosalicylic acids or oral glucocorticoids, their doses must remain stable for at least 2 weeks prior to enrollment and for the duration of the study. 6. Voluntarily sign the informed consent and be willing to follow the research procedures and complete the test in accordance with the protocol.

排除标准：

1. 诊断为未定型结肠炎、感染性结肠炎、缺血性结肠炎、暴发性结肠炎、中毒性巨结肠，或存在克罗恩病（CD）、肠结核、放射性肠炎、肠白塞病等UC以外的其他慢性肠道疾病者。 2. 既往从未接受过针对UC的任何治疗。 3. 筛选前3个月内参加过其他任何临床试验者（仅参与过临床试验筛选而未使用过试验药物者除外）。 4. 有酒精或药物滥用史，在入组前完全戒断时间未超过6个月者。 5. 入组前6周内或计划在研究期间或末次使用试验用药品后6周内接种任何活疫苗者。 6. 入组前４周内经历过重大创伤或重大手术者； 7. 有任何可能影响口服药物吸收的其他胃肠道疾病或接受过胃切除术、胃旁路术者。 8. 经研究者评估需要或正在接受全肠外营养和/或全肠内营养者。 9. 已知对试验药物或其成分过敏者。 10. 既往接受过或预期研究期间需要外科手术治疗溃疡性结肠炎，包括但不限于造口、回肠袋肛管吻合术、肠切除。 11. 既往接受过干细胞移植者（复杂肛瘘的局部干细胞疗法除外）。 12. 既往接受器官移植需要持续使用免疫抑制剂者。 13. 既往有带状疱疹病史或播散性单纯疱疹病史者。 14. 筛选前6个月内有临床重大感染者（例如，需要住院或肠外抗菌治疗，或机会性感染者）经研究者评估不适合参加本研究。 15. 已知患有人类免疫缺陷病毒（HIV）、乙肝病毒、丙肝病毒、梅毒感染，或其他活动性感染者： ? HIV抗体阳性者； ? 丙肝抗体Anti-HCV 检测阳性且HCV-RNA PCR检测结果阳性； ? 梅毒特异性抗体阳性者； ? 乙肝表面抗原（HBsAg）阳性者（对于乙肝表面抗原阴性，但乙肝核心抗体（HBcAb）阳性者，需进行HBV-DNA定量检测，若检测结果≥正常值下限，则不能入组本研究；若检测结果<正常值下限，则入组后需进行乙肝活动性监测）。 16. 有活动性结核病的证据，或者以前曾经有活动性结核病证据而且没有接受过适当的有记录的治疗；隐匿结核感染者，界定为γ干扰素释放试验（如结核菌感染T细胞斑点试验（T-SPOT））阳性者，且未经预防性抗结核治疗满3周（入组前）。 17. 筛选期肠道病原体、致病性卵、寄生虫或艰难梭菌毒素粪便检测结果呈阳性者（若经治疗后阴性，可由研究者评估进行复筛或入组）。 18. 患有恶性肿瘤或有恶性肿瘤病史，但经充分治疗或切除的皮肤非转移性基底细胞或鳞状细胞癌除外。 19. 有任何淋巴增殖性疾病病史者，如EB病毒（EBV）相关淋巴增殖性疾病、淋巴瘤、白血病、骨髓增生性疾病、多发性骨髓瘤的病史，或提示当前有淋巴疾病的体征和症状。 20. 筛选前12个月内有血栓性疾病史者，包括但不限于肺栓塞、深静脉血栓形成等，或筛选时经研究者评估存在血栓高风险因素（如有易导致高凝状态的遗传性疾病者）。 21. 筛选前6个月内发生过导致住院的心脑血管事件，包括但不限于不稳定型心绞痛、心肌梗死、纽约心脏病协会（NYHA）分类≥III级充血性心力衰竭、经皮冠状动脉腔内血管成形术、冠状动脉搭桥术、药物控制不佳的严重心律失常，短暂性脑缺血等脑血管意外。 22. 有未控制的心血管系统（如先心病、冠心病、慢性充血性心力衰竭等，无任何心血管相关症状的高血压除外）、呼吸系统（如慢性阻塞性肺疾病、支气管哮喘）、消化系统其他疾病、内分泌系统（控制良好的糖尿病除外）、血液系统、神经系统或精神病学障碍或任何其他严重和/或非稳定型疾病或病史，而且研究者认为这些疾病或病史在服用试验用药品的情况下会带来风险，或者会干扰数据的解读。 23. 接受以下任一治疗者： ? 筛选前既往接受过Janus激酶（JAK）抑制剂治疗，包括但不限于托法替尼、乌帕替尼、非戈替尼者； ? 入组前30天内：接受粪便菌群移植者；接受过治疗UC的中药或中成药者； ? 入组前2周内：接受过治疗性的灌肠剂或栓剂（例如：直肠给予氨基水杨酸制剂或糖皮质激素），内镜检查除外； ? 入组前2周内：硫唑嘌呤、6-巯基嘌呤和甲氨蝶呤； ? 入组前4周内：接受过免疫抑制剂，包括但不限于环孢素、霉酚酸酯、他克莫司、沙利度胺；系统性使用过中效或强效细胞色素P450 3A4酶（CYP3A4）抑制剂/诱导剂； ? 入组前8周内：接受过阿达木单抗、英夫利西单抗、维得利珠单抗等生物制剂（肿瘤坏死因子（TNF）-α拮抗剂、白介素（IL）-12/IL-23拮抗剂或α4β7整合素拮抗剂）治疗； ? 入组前12周内：接受过乌司奴单抗治疗。 ? 入组前2周内：口服抗生素。 24. 筛选时12导联心电图异常，而且研究者认为该异常具有临床意义并且参与本研究可能会给患者带来不可接受的风险（例如，男性QTcF＞450 ms，女性QTcF＞470 ms）。 25. 筛选时实验室检查有以下任一异常情况且研究者认为不宜参加本研究者： ? 血红蛋白<80.0 g/L； ? 血小板计数<80 x 10?/L； ? 白细胞计数<3.5 x 10?/L； ? 中性粒细胞计数<1.0 x 10?/L； ? 淋巴细胞计数<0.5 x 10?/L； ? 谷草转氨酶（AST）或谷丙转氨酶（ALT）>1.5 x正常值的上限（ULN）； ? 总胆红素≥ 1.5 x ULN； ? 肌酐>1 x ULN。 26. 妊娠期、哺乳期妇女；或育龄期妇女筛选时血妊娠检查结果阳性者；或在整个试验期间及研究结束后3个月内有生育计划者；或试验期间及研究结束后3个月内不愿采取一种或一种以上的物理性避孕措施者。 27. 研究者认为由于其他原因不适合参与本研究；或存在可能混淆或干扰研究药物的安全性、耐受性或药代动力学评估的其他情况。

Exclusion criteria：

1.Diagnosed with undefined colitis, infectious colitis, ischemic colitis, fulminant colitis, toxic megacolon, or other chronic intestinal diseases other than UC such as Crohn's disease (CD), intestinal tuberculosis, radiation enteritis, and intestinal belcet's disease. 2. Never received any previous treatment for UC. 3. Participated in any other clinical trial within 3 months prior to screening (except those who have only participated in clinical trial screening without using the experimental drug). 4. Subjects with a history of alcohol or drug abuse and complete abstinence for less than 6 months before enrollment. 5. Received any live vaccine within 6 weeks prior to enrollment or planned to receive any live vaccine during the study period or within 6 weeks after the last use of the investigational drug. 6. Experienced major trauma or major surgery within 4 weeks before enrollment; 7. Have any other gastrointestinal diseases that may affect the absorption of oral drugs or have undergone gastrectomy or gastric bypass surgery. 8. Assessed by investigator as needing or receiving total parenteral nutrition and/or total enteral nutrition. 9. Allergy to the test drug or its ingredients. 10. Surgical treatment for ulcerative colitis, including but not limited to ostomy, ileal pocket anal anastomosis, and intestinal resection, is required during prior or anticipated study. 11. Previously received stem cell transplantation (except local stem cell therapy for complex anal fistulas). 12. Received organ transplants in the past and require continuous use of immunosuppressants. 13. Previous history of herpes zoster or disseminated herpes simplex. 14. Clinically significant infections (e.g., requiring hospitalization or parenteral antimicrobial therapy, or opportunistic infections) in the 6 months prior to screening were assessed by investigator to be ineligible for participation in the study. 15. Known to be infected with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, syphilis, or other active persons: ? HIV-positive individuals; ? HCV antibody was positive for Anti-HCV and HCV RNA PCR was positive ? Syphilis specific antibody positive; ? Hepatitis B surface antigen (HBsAg) positive patients (HBSAG negative patients but HBcAb positive patients) need to undergo HBV-DNA quantitative detection. If the detection result is greater than or equal to the lower limit of normal value, they cannot be enrolled in this study; If the test result is lower than the lower limit of normal value, hepatitis B activity monitoring should be performed after enrollment). 16. Has evidence of active tuberculosis, or has previously had evidence of active tuberculosis and has not received appropriate documented treatment; Latent TB infection was defined as those who were positive for gamma interferon release tests (e.g., T cell SPOT tests for TB infection) and had not received preventive anti-TB therapy for at least 3 weeks (prior to enrolment). 17. Positive stool test results for enteric pathogens, pathogenic eggs, parasites or clostridium difficile toxins during the screening period (if negative after treatment, they can be evaluated by the researcher for re-screening or inclusion). 18. Have or have a history of malignant tumors, except for non-metastatic basal cell or squamous cell carcinoma of the skin that has been adequately treated or excised. 19. A history of any lymphoproliferative disease, such as Epstein-Barr virus (EBV) associated lymphoproliferative disease, lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or evidence of current signs and symptoms of lymphoproliferative disease. 20. History of thrombotic disease in the 12 months prior to screening, including but not limited to pulmonary embolism, deep vein thrombosis, etc., or those with a high risk of thrombotic factors (such as genetic diseases predisposition to hypercoagulability) assessed by the investigator at the time of screening. 21. Cardiovascular and cerebrovascular events leading to hospitalization in the 6 months prior to screening, including but not limited to unstable angina, myocardial infarction, NYHA classification >= III congestive heart failure, percutaneous intracavity coronary angioplasty, coronary artery bypass grafting, and medically poorly controlled severe arrhythmias, Transient cerebral ischemia and other cerebrovascular accidents. 22. Uncontrolled cardiovascular system (congenital heart disease, coronary heart disease, chronic congestive heart failure, etc.) Other than high blood pressure without any cardiovascular related symptoms), respiratory system (such as chronic obstructive pulmonary disease, bronchial asthma), other diseases of the digestive system, endocrine system (other than well-controlled diabetes), blood system, neurological or psychiatric disorders, or any other serious and/or unstable disease or medical history, Moreover, investigator believe that these diseases or medical histories pose a risk if the investigational product is taken, or may interfere with the interpretation of the data. 23. Those receiving any of the following treatments: ? Previous treatment with Janus kinase (JAK) inhibitors, including but not limited to tofacitinib, upatinib, and fegotinib, prior to screening; ? Within 30 days prior to enrollment: recipients of fecal flora transplantation; People who have received traditional Chinese medicine or proprietary Chinese medicine for UC treatment; ? Within 2 weeks prior to enrollment: received therapeutic enema or suppository (e.g., rectal administration of aminosalicylic acid or glucocorticoids), except for endoscopy; ? Within 2 weeks before enrollment: azathioprine, 6-mercaptopurine and methotrexate; ? Within 4 weeks prior to enrollment: received immunosuppressants, including but not limited to cyclosporin, mycophenolate, tacrolimus, thalidomide; Systematic use of moderate or potent cytochrome P450 3A4 enzyme (CYP3A4) inhibitors/inducers; ? Within 8 weeks prior to enrollment: received adalimumab, infliximab, vederizumab and other biologics (tumor necrosis factor (TNF) -α antagonist, interleukin-12 /IL-23 antagonist, or α4β7 integrin antagonist); ? Within the first 12 weeks of enrollment: received ulinumab therapy. ? Within 2 weeks before enrollment: oral antibiotics. 24. A 12-lead electrocardiogram abnormality at screening that the investigator determined was clinically significant and that participation in the study would pose an unacceptable risk to the patient (e.g., QTcF > 450 ms for men and 470 ms for women). 25. During screening, any of the following abnormal conditions were found in the laboratory examination and the investigator considered it inappropriate to participate in the study: ? Hemoglobin <80.0 g/L; ? Platelet count <80 x 10^9/L; ?White blood cell count <3.5 x 10^9/L; ? Neutrophil count <1.0 x 10^9/L; ? Lymphocyte count <0.5 x 10^9/L; ? Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN) ? Total bilirubin >= 1.5 x ULN; ? Creatinine >1 x ULN. 26. Pregnant and lactating women; Or women of childbearing age who have positive blood pregnancy test results during screening; Or had a birth plan throughout the trial period and within 3 months after the end of the study; Or unwilling to use one or more types of physical contraception during the trial and for three months after the end of the study. 27. The investigator believes that participation in this study is not appropriate for other reasons; Or other conditions that may confuse or interfere with the safety, tolerability, or pharmacokinetic evaluation of the investigational drug.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从From 2025-04-01 00:00:00 至 To 2025-10-01 00:00:00  

干预措施：

Interventions：

组别：

ENC1018胶囊给药组

样本量：

10

Group：

ENC1018 capsule administration group

Sample size：

干预措施：

每日口服一次ENC1018胶囊300mg，连续14天。

干预措施代码：

Intervention：

ENC1018 capsules were taken orally once a day for 14 days.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China 

Province：

Shanxi 

City：

 

单位(医院)：

第四军医大学唐都医院 

单位级别：

三甲 

Institution
hospital：

Tangdu Hospital, Fourth Military Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

各类不良事件（AE）和严重不良事件（SAE）；实验室测量值（血常规、血生化、凝血功能等）、生命体征等相对于基线的变化；

指标类型：

主要指标

Outcome：

Adverse events (AE) and Serious Adverse Events (SAE); Changes in laboratory measurements (blood routine, blood biochemistry, coagulation function, etc.), vital signs, etc., relative to baseline;

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ENC1018、Tofacitinib和Berberrubine在中重度活动性溃疡性结肠炎（UC）患者中的血药浓度和药代动力学参数，包括Tmax、Cmax、AUC0-tau、AUC0-last、AUC0-inf、t1/2、消除速率常数（λz）等。

指标类型：

主要指标

Outcome：

Plasma concentrations and pharmacokinetic parameters of ENC1018, Tofacitinib, and Berberrubine in patients with moderate-to-severe active ulcerative colitis (UC). Including Tmax, Cmax, AUC0-tau, AUC0-last, AUC0-inf, t1/2, elimination rate constant (λz), etc.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ENC1018、Tofacitinib和Berberrubine粪便PK参数：累积排泄量（Ae）、排泄分数（Fe）；

指标类型：

次要指标

Outcome：

Fecal PK parameters of ENC1018, Tofacitinib and Berberrubine: cumulative excretion amount (Ae), excretion fraction (Fe);

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

部分Mayo评分（在完整的改良Mayo评分中除去内镜评分）、排便次数（SF）评分和便血（RB）评分相比基线的变化；

指标类型：

次要指标

Outcome：

Changes in partial Mayo scores (excluding endoscopy scores from the complete modified Mayo score), defecation frequency (SF) scores, and blood in the stool (RB) scores from 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：

药效学生物标志物hsCRP和粪便钙卫蛋白相比基线期的变化

指标类型：

次要指标

Outcome：

Changes in the pharmacodynamic biomarker hsCRP and fecal calcarein from baseline

Type：

Secondary indicator

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

Faeces

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

无

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

None

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：

Blinding：

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）：

不共享数据

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

Not share IPD

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：

本研究将采用病例记录表。

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

This study will use Case Record Form.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-03-25 14:48:13