ChiCTR2500102168 版本V1.0 版本创建时间2025/05/09 15:36:39 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：

 ChiCTR2500102168 

最近更新日期：

Date of Last Refreshed on：

 2025-05-09 15:36:29 

注册时间：

Date of Registration：

 2025-05-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

青霉素过敏/耐药患者幽门螺杆菌感染的根除治疗：基于国产P-CAB替戈拉生二联疗法的真实世界研究

Public title：

Eradication Therapy for Helicobacter pylori Infection in Patients with Penicillin Allergy or Resistance: A Real-World Study Based on Domestic P-CAB Tegoprazan Dual Therapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

青霉素过敏/耐药患者幽门螺杆菌感染的根除治疗：基于国产P-CAB替戈拉生二联疗法的真实世界研究

Scientific title：

Eradication Therapy for Helicobacter pylori Infection in Patients with Penicillin Allergy or Resistance: A Real-World Study Based on Domestic P-CAB Tegoprazan Dual Therapy

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：

宋聪华 

研究负责人：

宋聪华 

Applicant：

Conghua Song 

Study leader：

Conghua Song 

申请注册联系人电话：

Applicant telephone：

 +86 137 0607 3412

研究负责人电话：

Study leader's
telephone：

+86 137 0607 3412

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：

 kesongs@163.com

研究负责人电子邮件：

Study leader's E-mail：

 kesongs@163.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：

福建省莆田市荔城区东圳路999号

研究负责人通讯地址：

福建省莆田市荔城区东圳路999号

Applicant address：

No. 999 Dongzhen East Road, Licheng District, Putian 351100, Fujian Province, China.

Study leader's address：

No. 999 Dongzhen East Road, Licheng District, Putian 351100, Fujian Province, 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：

莆田学院附属医院

Applicant's institution：

the Affiliated Hospital of Putian University

研究负责人所在单位：

莆田学院附属医院

Affiliation of the Leader：

the Affiliated Hospital of Putian University

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：

 莆医附伦[202582]

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：

莆田学院附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Affiliated Hospital of Putian University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-25 00:00:00

伦理委员会联系人：

郭刚

Contact Name of the ethic committee：

Guo Gang

伦理委员会联系地址：

福建省莆田市荔城区东圳路999号

Contact Address of the ethic committee：

No. 999 Dongzhen East Road, Licheng District, Putian 351100, Fujian Province, China.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 158 6008 9183

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：

莆田学院附属医院

Primary sponsor：

the Affiliated Hospital of Putian University

研究实施负责（组长）单位地址：

福建省莆田市荔城区东圳路999号

Primary sponsor's address：

No. 999 Dongzhen East Road, Licheng District, Putian 351100, Fujian Province, 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)：

福建

市(区县)：

Country：

China

Province：

Fujian

City：

单位(医院)：

莆田学院附属医院

具体地址：

福建省莆田市荔城区东圳路999号

Institution
hospital：

the Affiliated Hospital of Putian University

Address：

No. 999 Dongzhen East Road, Licheng District, Putian 351100, Fujian Province, China

经费或物资来源：

福建省自然科学基金、山东罗欣药业集团有限公司

Source(s) of funding：

Fujian Natural Science Foundation, Shandong Luoxin Pharmaceutical Group Co., LTD

研究疾病：

幽门螺杆菌  

Target disease：

Helicobacter pylori

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：

有效性：国产 P-CAB 替戈拉生分别联合呋喃唑酮、四环素的二联疗法对青霉素过敏或耐药患者幽门螺杆菌的根除效果。 安全性：治疗药物相关不良反应事件，评估二联疗法安全性。  

Objectives of Study：

Efficacy: The eradication effect of domestic P-CAB ticolassan combined with furazolidone and tetracycline on penicillin allergic or resistant patients with Helicobacter pylori. Safety: Treatment-related adverse events were observed, and the safety of dual therapy was evaluated.

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.幽门螺杆菌感染确诊：患者需通过以下至少两种方法确诊幽门螺杆菌感染，以确保诊断的准确性： ①13C或14C尿素呼气试验阳性，检测值高于正常参考范围（如13C尿素呼气试验DOB值>=4.0）； ②胃镜检查及快速尿素酶试验阳性，胃镜下可见胃黏膜存在不同程度的炎症、糜烂等病变，快速尿素酶试验试剂变色反应符合阳性标准； ③病理组织学检查发现幽门螺杆菌，通过胃黏膜活检组织，经特殊染色（如Warthin-Starry银染色、Giemsa染色等）后，在显微镜下观察到幽门螺杆菌的典型形态。 2.年龄范围：年龄在18周岁至60周岁之间。此年龄段人群身体机能相对稳定，能够较好地耐受治疗过程中的药物反应。同时，涵盖了不同年龄段的患者，可使研究结果在不同年龄层次中更具普适性。例如，18-35岁的青年群体新陈代谢较快，对药物的代谢和反应可能与50-75岁的中老年群体存在差异，纳入不同年龄段患者有助于全面评估药物疗效和安全性。 3.签署知情同意书：患者或其法定代理人充分了解研究目的、方法、可能的风险和受益后，自愿签署知情同意书。知情同意书内容应详细说明研究过程，包括治疗方案、用药剂量和时间、随访安排等，以及可能出现的不良反应及应对措施，确保患者在充分知情的情况下做出参与研究的决定。 4.无严重基础疾病：患者无严重的心肺功能障碍、肝肾功能衰竭、恶性肿瘤等可能影响治疗效果或增加研究风险的基础疾病。具体判断标准如下： 心肺功能方面，心功能分级需在NYHAⅠ-Ⅱ级，通过心脏超声检查评估左心室射血分数（LVEF）应>=50%；肺功能检查中，第1秒用力呼气容积占用力肺活量百分比（FEV1/FVC）>=70%，且无严重的慢性阻塞性肺疾病急性加重期表现。 肝肾功能方面，血清谷丙转氨酶（ALT）、谷草转氨酶（AST）不超过正常上限的1.5倍，血清肌酐（SCr）在正常参考范围内（男性53-106μmol/L，女性44-97μmol/L），或估算的肾小球滤过率（eGFR）>=60ml/（min?1.73m^2）。 5.恶性肿瘤方面，患者需无既往恶性肿瘤病史，或虽有既往恶性肿瘤病史，但已达到临床治愈标准（如手术切除后无瘤生存5年以上，且近期影像学检查未发现肿瘤复发迹象）。

Inclusion criteria

1. Diagnosis of Helicobacter pylori infection: Patients need to confirm the diagnosis of Helicobacter pylori infection by at least two of the following methods to ensure the accuracy of diagnosis: (1) The 13C or 14C urea breath test is positive, and the test value is higher than the normal reference range (e.g., the DOB value of the 13C urea breath test >=4.0); (2) The gastroscopy and rapid urease test were positive, and the gastric mucosa could be seen to have different degrees of inflammation, erosion and other lesions under gastroscopy, and the discoloration reaction of the rapid urease test reagent met the positive criteria; (3) Helicobacter pylori was found in histopathological examination, and the typical morphology of Helicobacter pylori was observed under the microscope after special staining (such as Warthin-Starry silver staining, Giemsa staining, etc.) through gastric mucosal biopsy. 2. Age range: between 18 and 60 years old. This age group is relatively stable and can tolerate drug reactions during treatment. At the same time, patients of different ages are covered, which makes the results of the study more universal across different age groups. For example, young people aged 18-35 years have a rapid metabolism and may have different metabolism and response to drugs than those of middle-aged and older people aged 50-75 years. 3. Signing of informed consent: Patients or their legal representatives voluntarily sign informed consent after fully understanding the research purpose, methods, possible risks and benefits. The content of the informed consent form should detail the research process, including the treatment plan, dosage and time of medication, follow-up arrangements, etc., as well as possible adverse reactions and countermeasures, so as to ensure that patients make a fully informed decision to participate in the study. 4. No serious underlying diseases: patients do not have serious cardiopulmonary dysfunction, liver and kidney failure, malignant tumors and other underlying diseases that may affect the treatment effect or increase the risk of the study. The specific judging criteria are as follows: In terms of cardiopulmonary function, the cardiac function grade should be in NYHAI.-II., and the left ventricular ejection fraction (LVEF) assessed by cardiac ultrasound should be >=50%; In pulmonary function tests, the percentage of forced expiratory volume occupied by force in 1 second (FEV1/FVC) was >=70%, and there were no severe acute exacerbations of chronic obstructive pulmonary disease. In terms of liver and kidney function, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) did not exceed 1.5 times the upper limit of normal, serum creatinine (SCr) was within the normal reference range (53-106 μmol/L for men and 44-97 μmol/L for women), or the estimated glomerular filtration rate (eGFR) >=60 ml/(min?1.73 m^2). 5. In terms of malignant tumors, patients should have no history of previous malignant tumors, or have a history of previous malignant tumors, but have reached the clinical cure criteria (such as tumor-free survival for more than 5 years after surgical resection, and no signs of tumor recurrence were found in recent imaging examinations).

排除标准：

1.对研究药物过敏：已知对替戈拉生、呋喃唑酮、四环素或其他相关药物过敏的患者，禁止入组。详细询问患者的药物过敏史，对于有药物过敏症状（如皮疹、瘙痒、呼吸困难、喉头水肿等）的患者，需进一步确认过敏药物种类，避免因药物过敏导致严重不良反应，影响患者健康和研究进程; 2.近期使用相关药物：在入组前4周内使用过抗生素、铋剂、质子泵抑制剂、钾离子竞争性酸阻滞剂等可能影响幽门螺杆菌检测结果或干扰研究药物疗效的药物。具体药物包括阿莫西林、甲硝唑、克拉霉素、枸橼酸铋钾、奥美拉唑、兰索拉唑、伏诺拉生等, 因为这些药物可能会改变幽门螺杆菌的活性或体内菌群平衡，导致检测结果不准确，影响对研究药物真实疗效的判断; 3.妊娠或哺乳期女性：出于对胎儿和婴儿安全的考虑，妊娠或哺乳期女性不纳入研究。通过详细询问月经史、进行妊娠试验（如尿妊娠试验、血β-HCG检测）等方式，准确判断女性患者的妊娠和哺乳状态。研究药物对胎儿和婴儿的安全性尚未明确，避免潜在的风险; 4.精神疾病或认知障碍：患有严重精神疾病（如精神分裂症、躁狂抑郁症等）或认知障碍（如老年痴呆症、严重脑损伤导致的认知功能障碍等），无法配合完成研究过程中的各项检查、治疗和随访的患者。通过专业的精神科评估量表（如简易精神状态检查表MMSE、汉密尔顿抑郁量表HAMD等）对患者的精神和认知状态进行评估，确保患者能够准确理解并遵循研究要求，保证研究数据的可靠性; 5.弱势群体：主要包括儿童、老年人、残疾人、精神病患者、失业者、贫困者、下岗职工、灾难中的求助者、农民工、非正规就业者以及在劳动关系中处于弱势地位的人。本研究虽未刻意针对弱势群体，但在入组和研究过程中充分考虑了各类人群的特点和权益，严格按照既定标准执行，确保研究的科学性与伦理性; 6.依从性差：根据研究者的判断，患者可能存在依从性问题，如不能按时服药、不配合随访等。在筛选患者时，详细了解患者的生活习惯、工作情况等，对于工作繁忙、经常出差或有不良生活习惯（如长期酗酒、吸毒等）可能影响按时服药和随访的患者，需谨慎评估其依从性, 良好的依从性是保证研究结果准确性的关键，依从性差的患者可能会导致研究数据偏差，影响研究结论; 7.其他特殊情况：患者若存在胃肠道手术史（如胃大部切除术、小肠切除术等），可能影响药物的吸收和胃肠道正常生理功能，干扰研究结果，此类患者也应排除在外。对于有其他特殊疾病（如自身免疫性疾病、严重血液系统疾病等）正在接受特殊治疗，可能与研究药物产生相互作用的患者，同样不纳入研究。

Exclusion criteria：

1. Allergy to the study drug: Patients with known allergy to tegolasen, furazolidone, tetracycline or other related drugs are prohibited from enrollment. For patients with drug allergy symptoms (such as rash, itching, dyspnea, laryngeal edema, etc.), the type of allergic drug should be further confirmed to avoid serious adverse reactions caused by drug allergy, which will affect the patient's health and research process; 2. Recent use of related drugs: use of antibiotics, bismuth, proton pump inhibitors, potassium competitive acid blockers and other drugs that may affect the test results of Helicobacter pylori or interfere with the efficacy of the study drug within 4 weeks before enrollment. Specific drugs include amoxicillin, metronidazole, clarithromycin, bismuth potassium citrate, omeprazole, lansoprazole, vornorrasine, etc., because these drugs may change the activity of Helicobacter pylori or the balance of microflora in the body, resulting in inaccurate test results and affecting the judgment of the true efficacy of the study drug; 3. Pregnant or lactating females: Pregnant or lactating females were not included in the study due to the safety of the fetus and infant. The pregnancy and lactation status of female patients can be accurately determined by asking for a detailed menstrual history and performing pregnancy tests (such as urine pregnancy test and blood β-HCG test). The safety of the study drug on the fetus and infant has not been established to avoid potential risks; 4. Mental illness or cognitive impairment: patients with severe mental illness (such as schizophrenia, manic-depressive disorder, etc.) or cognitive impairment (such as Alzheimer's disease, cognitive dysfunction caused by severe brain injury, etc.), and cannot cooperate with the completion of various examinations, treatments and follow-up in the course of the study. The mental and cognitive status of patients is assessed through professional psychiatric assessment scales (such as Mini-Mental State Examination (MMSE), Hamilton Depression Rating Scale (HAMD, etc.) to ensure that patients can accurately understand and follow the requirements of the study and ensure the reliability of the research data. 5. Vulnerable groups: mainly including children, the elderly, the disabled, the mentally ill, the unemployed, the poor, laid-off workers, those seeking help in disasters, migrant workers, informal workers, and those in a disadvantaged position in labor relations. Although this study did not deliberately target vulnerable groups, the characteristics and rights and interests of various groups of people were fully considered in the enrollment and research process, and it was strictly implemented in accordance with the established standards to ensure the scientificity and ethics of the study. 6. Poor compliance: According to the judgment of the investigator, the patient may have compliance problems, such as not being able to take medication on time, not cooperating with follow-up, etc. For patients who are busy with work, often travel or have bad lifestyle habits (such as long-term alcoholism, drug abuse, etc.) that may affect the timely medication and follow-up, it is necessary to carefully evaluate their compliance, good compliance is the key to ensure the accuracy of the research results, and patients with poor compliance may lead to bias in the study data and affect the research conclusions; 7. Other special circumstances: If the patient has a history of gastrointestinal surgery (such as gastrectomy, small bowel resection, etc.), which may affect the absorption of drugs and the normal physiological function of the gastrointestinal tract, and interfere with the research results, such patients should also be excluded. Patients with other special diseases (such as autoimmune diseases, severe hematologic diseases, etc.) who are receiving special treatment and may interact with the study drug are also excluded from the study.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

替戈拉生二联疗法（一）组

样本量：

 30

Group：

Tegoprazan-Based Dual Therapy (I) Group

Sample size：

干预措施：

替戈拉生联合呋喃唑酮

干预措施代码：

Intervention：

Tegoprazan combined with furazolidone

Intervention code：

组别：

替戈拉生二联疗法（二）组

样本量：

 30

Group：

Tegoprazan-Based Dual Therapy (II) Group

Sample size：

干预措施：

替戈拉生联合四环素

干预措施代码：

Intervention：

Tegoprazan combined with tetracycline

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

  

Country：

China

Province：

Fujian

City：

单位(医院)：

 莆田学院附属医院 

单位级别：

 三甲 

Institution
hospital：

the Affiliated Hospital of Putian University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

根除率

指标类型：

主要指标

Outcome：

Eradication rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药物相关不良事件

指标类型：

次要指标

Outcome：

Drug-related adverse events

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 60 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）：

在本研究中，随机序列的生成由不参与患者招募的独立统计人员（院内统计专业人员）负责，采用计算机随机数生成器（如Excel的RAND()函数）或简单随机数字表生成60例患者的分配序列，确保替戈拉生联合呋喃唑酮组与替戈拉生联合四环素组的1:1比例分配，并将结果密封于编号信封中，以保障随机分配的公平性和隐蔽性。

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

The randomization sequence was generated by an independent statistician (an in-hospital statistician) who was not involved in patient recruitment. A computerized random number generator (e.g., the RAND() function of Excel) or a simple random number table was used to generate the allocation sequence for 60 patients. A 1:1 ratio of assignment to the tigorassan-plus-furazolidone group versus the tigorassan-plus-tetracycline group was ensured, and the results were sealed in numbered envelopes to ensure fairness and concealability of the random assignment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

在本研究中，由于替戈拉生联合呋喃唑酮与四环素二联疗法的用药方案存在差异（如服药次数和剂量不同），无法实现完全双盲，但采用评估者盲法以降低偏倚：负责疗效评估的关键人员（如研究人员、13C/14C尿素呼气试验检测人员及数据分析人员）不参与治疗分配且对患者分组信息保持盲态，仅依据客观检查结果（如胃黏膜改善情况、根除率检测数据）进行评价，确保疗效与安全性分析的客观性，从而在可行范围内最大程度保障研究的科学性。

Blinding：

In this study, full double-blinding could not be achieved due to differences in the dosing schedule (e.g., the number and dose of doses) of ticolassan plus furazolidone versus tetracycline dual therapy, but assessor blinding was used to reduce bias: The key personnel responsible for efficacy evaluation (such as researchers, 13C/14C urea breath test technicians and data analysts) were not involved in treatment allocation and were blinded to patient group information, and only evaluated based on objective examination results (such as gastric mucosal improvement and eradication rate test data) to ensure the objectivity of efficacy and safety analysis. So as to ensure the scientific validity of the study to the greatest extent possible.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否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）：

无

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

None

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：

病例记录表

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

Case Record Form, CRF

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：

  2025-05-09 15:36:29