今天是:2019-06-17 星期一

曾庆磊医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 丙酚替诺福韦阻断乙肝病毒母婴传播的安全性、有效性和停药时机的真实世界观察性研究
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注册号:

Registration number:

ChiCTR1900023803 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

曾庆磊医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 丙酚替诺福韦阻断乙肝病毒母婴传播的安全性、有效性和停药时机的真实世界观察性研究  

Public title:

Real-world observational study for the safety, efficacy and optimal withdrawal time of tenofovir alafenamide for the prevention of mother-to-child transmission of hepatitis B virus 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

丙酚替诺福韦阻断乙肝病毒母婴传播的安全性、有效性和停药时机的真实世界观察性研究  

Scientific title:

Real-world observational study for the safety, efficacy and optimal withdrawal time of tenofovir alafenamide for the prevention of mother-to-child transmission of hepatitis B virus 

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:

曾庆磊 

研究负责人:

曾庆磊 

Applicant:

Qinglei Zeng 

Study leader:

Qinglei Zeng 

申请注册联系人电话:

Applicant telephone:

+86 15838120512 

研究负责人电话:

Study leader's telephone:

+86 15838120512 

申请注册联系人传真 :

Applicant Fax:

+86 15838120512 

研究负责人传真:

Study leader's fax:

+86 15838120512 

申请注册联系人电子邮件:

Applicant E-mail:

zengqinglei2009@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zengqinglei2009@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:

河南省郑州市建设东路1号郑州大学第一附属医院感染病科  

研究负责人通讯地址:

河南省郑州市建设东路1号郑州大学第一附属医院感染病科  

Applicant address:

1 Jianshe Road East, Zhengzhou, Henan, China  

Study leader's address:

1 Jianshe Road East, Zhengzhou, Henan, 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:

郑州大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Zhengzhou University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

郑州大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Zhengzhou University 

研究实施负责(组长)单位地址:

河南省郑州市建设东路1号郑州大学第一附属医院感染病科  

Primary sponsor's address:

1 Jianshe Road East, Zhengzhou, Henan, 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):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州大学第一附属医院

具体地址:

建设东路1号

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University

Address:

1 Jianshe Road East

国家:

中国

省(直辖市):

陕西

市(区县):

延安

Country:

China

Province:

Shaanxi

City:

Yan'an

单位(医院):

延安大学附属医院

具体地址:

宝塔区中心街250号

Institution
hospital:

The Affiliated Hospital of Yan'an University

Address:

250 Central Street, Baota District

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

河南省人民医院

具体地址:

纬五路7号

Institution
hospital:

Henan Provincial People’s Hospital

Address:

7 Weiwu Road

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州市第六人民医院

具体地址:

京广南路29号

Institution
hospital:

The Sixth Hospital of Zhengzhou

Address:

29 Jingguang Road South

国家:

中国

省(直辖市):

河南

市(区县):

洛阳

Country:

China

Province:

Henan

City:

Luoyang

单位(医院):

洛阳市中心医院

具体地址:

中州中路288号

Institution
hospital:

Luoyang Central Hospital

Address:

288 Middle Zhongzhou Road

经费或物资来源:

国家自然科学基金; 河南省科技厅、教育厅、卫生健康委员会基金项目 

Source(s) of funding:

The National Natural Science Foundation of China; Foundations from Henan Provincial Department of Science and Technology, Education and Health. 

研究疾病:

慢性乙型肝炎 

Target disease:

Chronic hepatitis B 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

本真实世界研究旨在回顾性观察丙酚替诺福韦阻断乙肝病毒母婴传播的安全性、有效性和最佳停药时机。 

Objectives of Study:

This real-world observational study aimed to retrospectively investigate the safety, efficacy and optimal withdrawal time of tenofovir alafenamide for the prevention of mother-to-child transmission of hepatitis B virus. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)妊娠期孕妇;(2)年龄在20-40岁之间;(3)被诊断为HBeAg阳性慢性乙肝病毒感染。 

Inclusion criteria

1. Pregnant womon; 2. Aged 20-40 years; 3. Diagnosed with HBeAg positive chronic hepatitis B virus infection.  

排除标准:

(1)有乙肝肝硬化、肝癌病史;(2)合并HBV之外的其他嗜肝病毒感染、酒精性肝病、脂肪性肝病、自身免疫性肝病、药物性肝损伤、遗传代谢性肝病;(3)合并高血压、糖尿病等系统性疾病;(4)有精神和心理疾患。 

Exclusion criteria:

1. Comorbided with cirrhosis and/or hepatocellular carcinoma; 2. Coinfected with other hepatotropic virus (such as hepatitis C virus, et al);comorbided with alcoholic liver diseases,fatty liver diseses, autoimmune liver hepatitis, drug-induced liver injury and genetic liver diseases; 3. Comorbided with systemic disorders (such as hypertension,diabetes and human immunodeficiency virus infection, et al); 4. Comorbided with psychiatric disorders and psychological diseases. 

研究实施时间:

Study execute time:

From2019-06-11To 2020-12-31 

干预措施:

Interventions:

组别:

第一组

样本量:

50

Group:

Group 1

Sample size:

干预措施:

妊娠第28周开始服用丙酚替诺福韦,产后立即停用

干预措施代码:

Intervention:

Tenofovir alafenamide was administered at the 28th week of pregnancy and discontinued immediately after delivery.

Intervention code:

组别:

第二组

样本量:

50

Group:

Group 2

Sample size:

干预措施:

妊娠第28周开始服用丙酚替诺福韦,产后1月停用

干预措施代码:

Intervention:

Tenofovir alafenamide was administered at the 28th week of pregnancy and discontinued one month after delivery.

Intervention code:

组别:

第三组

样本量:

50

Group:

Group 3

Sample size:

干预措施:

妊娠第28周开始服用丙酚替诺福韦,产后3月停用

干预措施代码:

Intervention:

Tenofovir alafenamide was administered at the 28th week of pregnancy and discontinued three month after delivery.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

延安 

Country:

China 

Province:

Shaanxi 

City:

Yan'an 

单位(医院):

延安大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Yan'an University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial People’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州市第六人医院 

单位级别:

三级综合 

Institution
hospital:

The Sixth Hospital of Zhengzhou  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

洛阳 

Country:

China 

Province:

Henan 

City:

Luoyang 

单位(医院):

洛阳市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Luoyang Central Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

丙酚替诺福韦的母婴安全性

指标类型:

主要指标 

Outcome:

Safety of tenofovir alafenamide for mothers and infants

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HBV的母婴传播阻断成功率

指标类型:

主要指标 

Outcome:

Successful rate of prevention for mother-to-child transmission of hepatitis B virus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙酚替诺福韦的停药时机

指标类型:

主要指标 

Outcome:

Withdrawal time of tenofovir alafenamide

Type:

Primary 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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 40 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

不适用:本研究拟从临床住院和门诊系统中收集相关数据进行回顾性的分析和研究。

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

Not Applicable.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

EXCEL

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

EXCEL

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-12
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