今天是:2020-08-03 星期一

恩替卡韦vs替诺福韦治疗初治的慢性乙型肝炎相关失代偿性肝硬化患者的肝细胞癌风险:一项基于病历记录单中心医院队列研究
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注册号:

Registration number:

ChiCTR2000034573 

最近更新日期:

Date of Last Refreshed on:

2020-07-11 

注册时间:

Date of Registration:

2020-07-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

恩替卡韦vs替诺福韦治疗初治的慢性乙型肝炎相关失代偿性肝硬化患者的肝细胞癌风险:一项基于病历记录单中心医院队列研究 

Public title:

Entecavir vs tenofovir in the treatment of hepatocellular carcinoma risk in newly treated patients with chronic hepatitis B-related decompensated cirrhosis: a medical records based study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

恩替卡韦vs替诺福韦治疗初治的慢性乙型肝炎相关失代偿性肝硬化患者的肝细胞癌风险:一项单中心医院队列研究 

Scientific title:

Entecavir vs tenofovir in the treatment of hepatocellular carcinoma risk in newly treated patients with chronic hepatitis B-related decompensated cirrhosis: a single-center hospital liver study 

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:

韩莹 

研究负责人:

丁惠国 

Applicant:

Ying Han 

Study leader:

Huiguo Ding 

申请注册联系人电话:

Applicant telephone:

+86 13520809804 

研究负责人电话:

Study leader's telephone:

+86 13911683832 

申请注册联系人传真 :

Applicant Fax:

+86 10-63295525 

研究负责人传真:

Study leader's fax:

+86 10-63295525 

申请注册联系人电子邮件:

Applicant E-mail:

gladyshanying@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dinghuiguo@medmail.com.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:

北京市丰台区右安门外西头条8号 

研究负责人通讯地址:

北京市丰台区右安门外西头条8号 

Applicant address:

8 Toutou Lane West, You'anmen Outer Street, Fengtai District, Beijing, China 

Study leader's address:

8 Toutou Lane West, You'anmen Outer Street, Fengtai District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100069 

研究负责人邮政编码:

Study leader's postcode:

100069 

申请人所在单位:

首都医科大学附属北京佑安医院 

Applicant's institution:

Beijing You'an Hospital Affiliated to Capital Medical 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:

京佑科伦字【2020】083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:

首都医科大学附属北京佑安医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing You'an Hospital Affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-15 

伦理委员会联系人:

孟莎 

Contact Name of the ethic committee:

Sha Meng 

伦理委员会联系地址:

北京市丰台区右安门外西头条8号 

Contact Address of the ethic committee:

8 Toutou Lane West, You'anmen Outer Street, Fengtai District, Beijing, China 

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:

首都医科大学附属北京佑安医院 

Primary sponsor:

Beijing You'an Hospital Affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区右安门外西头条8号 

Primary sponsor's address:

8 Toutou Lane West, You'anmen Outer Street, Fengtai District, Beijing, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

首都医科大学附属北京佑安医院

具体地址:

北京市丰台区右安门外西头条8号

Institution
hospital:

Beijing You'an Hospital Affiliated to Capital Medical University

Address:

8 Toutou Lane West, You'anmen Outer Street, Fengtai District

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

失代偿期乙肝肝硬化 

Target disease:

Decompensated hepatitis B cirrhosis patients 

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:

其它 

Study phase:

N/A 

研究目的:

比较长期服用TDF药或ETV药的乙肝肝硬化患者,长期的疗效和安全性,以及长期抗病毒治疗对肝硬化患者长期预后影响。 

Objectives of Study:

Compare the long-term efficacy and safety of hepatitis B cirrhosis patients who have been taking TDF or ETV drugs for a long time, and the impact of long-term antiviral therapy on the long-term prognosis of patients with liver cirrhosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

(1)抗病毒组 ①诊断为失代偿期乙型肝炎肝硬化,诊断符合2019年中华医学会肝病学分会《肝硬化诊治指南》的诊断标准。 ②在我院定期随诊,可获得较完整的随访数据。 ③既往或者半年内未应用恩替卡韦、替诺福韦、替比夫定等抗病毒治疗,HBsAg阳性,HBVDNA >102IU/ml(Cabos e601,罗氏诊断,德国)。于我院病历库中能查到长期的用药记录,规律服药2年。用核苷(酸)类似物前,患者知情同意。 ④年龄 18-80 岁;性别不限。 (2)未抗病毒组 ①诊断为失代偿期乙型肝炎肝硬化,诊断符合2019年中华医学会肝病学分会《肝硬化诊治指南》的诊断标准。 ②在我院定期随诊,可获得较完整的随访数据。 ③未服用过抗病毒药物,生存期至少6个月 ④年龄 18-80 岁;性别不限。 

Inclusion criteria

1. Antiviral group: (1) Patients with decompensated hepatitis B cirrhosis were diagnosed according to the diagnostic criteria of liver cirrhosis diagnosis and treatment guidelines issued by hepatology branch of Chinese Medical Association in 2019; (2) In our hospital, regular follow-up can obtain more complete follow-up data of patients; (3) Patients who had not been treated with entecavir, tenofovir or telbivudine before or within half a year showed positive HBsAg and HBV DNA > 102 IU / ml (Cabos E601, Roche diagnosis, Germany). The long-term medication records can be found in the medical record database of our hospital, and the regular medication for 2 years. Before using nucleoside (acid) analogues, the patients had informed consent. (4) Aged 18 to 80 years old. 2. Non antiviral group: (1) Patients with decompensated hepatitis B cirrhosis were diagnosed according to the diagnostic criteria of liver cirrhosis diagnosis and treatment guidelines issued by hepatology branch of Chinese Medical Association in 2019; (2) Patients with complete follow-up data can be obtained by regular follow-up in our hospital; (3) Patients who had not taken antiviral drugs and had a survival time of at least 6 months; (4) Aged 18 to 80 years old. 

排除标准:

(1)合并其他肝炎病毒感染(例如,HAV,HCV,HEV,EBV等)。 (2)长期使用肝毒性药物(如抗肿瘤,抗结核,神经系统药物等)。 (3)原发性或转移性肝癌。 (4)在抗病毒治疗期间停药超过6个月的患者。 (5)患有不受控制的心血管,呼吸,消化,神经,泌尿和其他严重疾病的患者。 (6)孕妇或哺乳期妇女。 (7)乙型肝炎失代偿性肝硬化合并酒精性肝病的患者。 (8)慢性肝功能衰竭或Child-pugh评分大于14时急性发作。 (9)其他研究者认为不符合该研究条件的患者。 

Exclusion criteria:

1. Patients with other hepatitis virus infection (such as HAV, HCV, HEV, EBV, etc.); 2. Patients who use hepatotoxic drugs for a long time (such as anti-tumor, anti tuberculosis, nervous system drugs, etc.); 3. Patients with primary or metastatic liver cancer; 4. Patients who have stopped taking antiviral therapy for more than 6 months; 5. Patients with uncontrolled cardiovascular, respiratory, digestive, neurological, urinary and other serious diseases; 6. Pregnant or lactating women; 7. Patients with decompensated liver cirrhosis complicated with alcoholic liver disease; 8. Patients with chronic liver failure or acute attack when child Pugh score is greater than 14; 9. Patients considered by other researchers not to meet the study conditions. 

研究实施时间:

Study execute time:

From2020-07-10To 2024-07-10 

征募观察对象时间:

Recruiting time:

From2020-07-10To 2020-10-10 

干预措施:

Interventions:

组别:

恩替卡韦

样本量:

12385

Group:

ETV cohort

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

替诺福韦

样本量:

651

Group:

TDF cohort

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing You'an Hospital Affiliated to Capital Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肝癌发生率

指标类型:

主要指标 

Outcome:

Incidence of hepatocellular carcinoma

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乙肝病毒载量定量

指标类型:

次要指标 

Outcome:

HBV DNA

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:

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 years
最大 Max age 80 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):

N/A

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

N/A

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:

即时公开/Real time access

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):

与研究者联系

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

Contact the researcher

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-10
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