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注册号: Registration number: |
ChiCTR2600126666 |
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最近更新日期: Date of Last Refreshed on: |
2026-06-13 09:29:57 |
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注册时间: Date of Registration: |
2026-06-13 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
昂拉地韦片治疗甲型流感病毒感染患者的真实世界研究 |
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Public title: |
Real-World Study of Onradivir Tablets in Patients with Influenza A Virus Infection |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
昂拉地韦片治疗甲型流感病毒感染患者的真实世界研究 |
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Scientific title: |
Real-World Study of Onradivir Tablets in Patients with Influenza A Virus Infection |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
占扬清 |
研究负责人: |
钟南山 |
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Applicant: |
Zhan Yangqing |
Study leader: |
Zhong Nanshan |
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申请注册联系人电话: Applicant telephone: |
+86 15820278266 |
研究负责人电话:
Study leader's |
+86 20 83062938 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
zhan071119@163.com |
研究负责人电子邮件: Study leader's E-mail: |
nanshan@vip.163.com |
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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): |
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申请注册联系人通讯地址: |
广州市荔湾区桥中中路28号 |
研究负责人通讯地址: |
广州市越秀区沿江西路151号 |
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Applicant address: |
28, Qiaozhong Middle Road, Liwan District, Guangzhou |
Study leader's address: |
151 Yanjiang Road West, Yuexiu, Guangzhou, Guangdong, China |
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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: |
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申请人所在单位: |
广州医科大学附属第一医院 |
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Applicant's institution: |
The First Affiliated Hospital Of Guangzhou Medical University |
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研究负责人所在单位: |
广州医科大学附属第一医院 |
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Affiliation of the Leader: |
The First Affiliated Hospital of Guangzhou Medical University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
ES-2025-289-01, ES-2025-289-02 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
广州医科大学附属第一医院科研项目审查伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Scientific Research of the First Affiliated Hospital of Guangzhou Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-01-28 00:00:00 | ||
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伦理委员会联系人: |
张晓露 |
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Contact Name of the ethic committee: |
Zhang Xiaolu |
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伦理委员会联系地址: |
广州市越秀区沿江西路151号 |
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Contact Address of the ethic committee: |
151 Yanjiang Road West, Yuexiu, Guangzhou, Guangdong, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 20 81566265 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
gyfy_ec@163.com |
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研究实施负责(组长)单位: |
广州医科大学附属第一医院 |
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Primary sponsor: |
The First Affiliated Hospital of Guangzhou Medical University |
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研究实施负责(组长)单位地址: |
广州市越秀区沿江西路151号 |
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Primary sponsor's address: |
151 Yanjiang Road West, Yuexiu, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
广东瑞诺威生物科技有限公司 |
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Source(s) of funding: |
Guangdong Raynovent Biotech Co., Ltd |
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研究疾病: |
甲型流感病毒感染 |
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Target disease: |
Influenza A virus infection |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
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Study phase: |
4 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
主要目的: 在真实世界临床场景中系统评估昂拉地韦片短疗程与标准疗程对甲型流感病毒感染患者的实际疗效,为后续药物说明书的修订提供循证依据。 次要目的: 1、耐药性监测:通过病毒学采样、基因测序和药物敏感性检测,探究昂拉地韦片在甲型流感病毒感染患者中的潜在耐药性,为抗病毒药物的规范化使用及公共卫生防控策略提供参考; 2、安全性评估:在真实世界场景中全面监测和评估昂拉地韦片在甲型流感病毒感染患者中的安全性,识别潜在的不良反应及风险因素,提供其真实世界中的安全用药证据; 3、家庭/密接者保护性探索:通过对患者共同居住者的后续感染监测,探索昂拉地韦片在减少家庭密切接触者甲型流感感染风险方面的潜在保护作用。 |
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Objectives of Study: |
Primary Objectives To systematically evaluate the real-world clinical effectiveness of short-course vs. standard-course treatment with Onladepine Tablets in patients infected with influenza A virus, so as to provide evidence-based support for the subsequent revision of the drug instructions. Secondary Objectives 1. Drug Resistance Monitoring: To investigate the potential drug resistance of Onladepine Tablets in patients with influenza A virus infection through virological sampling, gene sequencing and drug susceptibility testing, thereby providing a reference for the standardized use of antiviral drugs and public health prevention and control strategies. 2. Safety Assessment: To comprehensively monitor and assess the safety of Onladepine Tablets in real-world settings among patients infected with influenza A virus, identify potential adverse reactions and risk factors, and furnish real-world evidence for its safe clinical use. 3. Exploration of Protective Effects on Household/Close Contacts: To explore the potential protective effect of Onladepine Tablets in reducing the risk of influenza A infection among household close contacts of patients through follow-up infection monitoring of individuals living with the patients. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.合并有严重心、肝、肾、肺和血液系统等严重原发疾病者,研究者判定存在较大安全性风险不适合参加者; |
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Exclusion criteria: |
1. Subjects with severe underlying diseases including serious cardiac, hepatic, renal, pulmonary, hematological and other systemic disorders, or those deemed by the investigator to have significant safety risks and thus unsuitable for participation. 2. Pregnant or lactating females. 3. Severe or critical influenza subjects requiring hospitalization. 4. Use of anti-influenza A antiviral agents within 30 days prior to enrollment. 5. Participation in other interventional studies within 30 days prior to enrollment. 6. Any other conditions deemed inappropriate for participation by the investigator. |
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研究实施时间: Study execute time: |
从 From 2025-12-25 00:00:00至 To 2028-12-29 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-06-30 00:00:00 至 To 2027-12-31 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
随机表由不参与本试验统计分析工作的统计人员依据SAS软件的PLAN过程产生随机号。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The randomization table will be generated by a statistician who is not involved in the statistical analysis of this trial, using the PLAN procedure in SAS software to produce random numbers. |
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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 |
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盲法: |
开放标签 |
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Blinding: |
Open-label study |
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是否共享原始数据: IPD sharing |
否No |
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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 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Not shared |
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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: |
电子化患者报告结局; 电子采集和管理系统。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
ePRO Electronic Patient-Reported Outcomes;Electronic Data Capture |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |