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Sustained Response After Discontinuation of Long-term Nucleos (t) ide Analogue Therapy in Chronic Hepatitis B Patients
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注册号:

Registration number:

ChiCTR-OOC-17013970 

最近更新日期:

Date of Last Refreshed on:

2017-12-15 

注册时间:

Date of Registration:

2017-12-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

长期核苷类药物抗乙肝病毒治疗后停药的持久应答研究 

Public title:

Sustained Response After Discontinuation of Long-term Nucleos (t) ide Analogue Therapy in Chronic Hepatitis B Patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

长期核苷(酸)类药物治疗慢乙肝停药后持久应答的研究 

Scientific title:

Sustained Response After Discontinuation of Long-term Nucleos (t) ide Analogue Therapy in Chronic Hepatitis B Patients 

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:

彭劼 

研究负责人:

彭劼 

Applicant:

Jie Peng 

Study leader:

Jie Peng 

申请注册联系人电话:

Applicant telephone:

+86 13802515784 

研究负责人电话:

Study leader's telephone:

+86 13802515784 

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:

pjie138@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pjie138@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:

中国广东省广州市广州大道北1838号南方医科大学南方医院肝病中心  

研究负责人通讯地址:

中国广东省广州市广州大道北1838号南方医科大学南方医院肝病中心  

Applicant address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China 

Study leader's address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510515 

研究负责人邮政编码:

Study leader's postcode:

510515 

申请人所在单位:

南方医院 

Applicant's institution:

NanFang hospital 

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:

NFEC-201209-K3 

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:

南方医院医学伦理委员会 

Name of the ethic committee:

Nanfang Hospital Medical Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2012-10-01 

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:

南方医院 

Primary sponsor:

Nanfang hospital 

研究实施负责(组长)单位地址:

中国广东省广州市广州大道北1838号南方医科大学南方医院 

Primary sponsor's address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医院

具体地址:

中国广东省广州市广州大道北1838号南方医科大学南方医院

Institution
hospital:

Nanfang hospital

Address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学附属第三医院

具体地址:

广东省广州市天河区中山大道西183号

Institution
hospital:

Third Affiliated Hospital of Southern Medical University

Address:

183 Zhongshan Avenue, Tianhe District, Guangzhou, China

经费或物资来源:

南方医科大学 

Source(s) of funding:

Southern Medical University,China 

研究疾病:

慢性乙型病毒性肝炎 

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:

其它 

Study phase:

N/A 

研究目的:

比较长期核苷(酸)类药物治疗后,不同巩固治疗时间长度间的停药患者临床复发情况,以期探索最佳的巩固治疗时间。  

Objectives of Study:

After long-term nucleoside (acid) treatment, the clinical recurrence of drug-withdrawal patients with different duration of consolidation treatment was compared in order to explore the best consolidation treatment time. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1)18-60岁(含18岁和60岁),男性或女性。 2)进行任何与研究相关的步骤前,理解并签署知情同意书,并且遵守研究要求。 3)对于治疗前HBeAg阳性患者,持续口服核苷(酸)类药物治疗至HBV DNA在检测线以下、ALT复常、HBeAg发生血清转换后再继续巩固治疗至少24个月。 4)对于治疗前HBeAg阴性患者,治疗至HBV DNA在检测线以下、ALT复常后再继续巩固治疗至少36个月。 5)治疗前为代偿性肝病,无肝硬化证据。 6)筛选时WBC > 3.5G/L, PLT > 100G/L,AFP < 20ng/ml,ALT、AST正常,HBV DNA在检测线以下。 7)同意不参加任何其它研究。 

Inclusion criteria

1. Aged 18 to 60 years old male or female; 2. Patients signed the informed consent form; 3. For HBeAg positive patients, therapy with nucleos(t)ide analogs should be received for at least 24 months with undetectable HBV DNA, normal ALT and HBeAg seroconversion; 4. For HBeAg negative patients, therapy with nucleos(t)ide analogs should be received for at least 36 months with undetectable HBV DNA and normal ALT; 5. Patients diagnosed as compensatory liver disease and with no evidence of liver cirrhosis before the therapy; 6. Patients with WBC > 3.5G/L, PLT > 100G/L, AFP < 20ng/ml, normal ALT and AST, and undetectable HBV DNA at base line; 7. Patient agreed not to participate in any other study. 

排除标准:

符合下列任一条件的受试者将不能入选本研究。 1)研究者判断认为患者依从性不佳或无法依从研究要求。 2)既往治疗前有失代偿肝病的临床症状,包括但不限于:TBIL≥2倍正常值上线(ULN),凝血酶原时间较ULN延长≥3秒,血清白蛋白低于32g/l,有肝功能失代偿病史(如腹水、静脉曲张破裂出血,或肝性脑病)。超声或放射检查发现可疑结节或AFP>20ng/mL。 3)停药前有肝活检的患者,提示有明显的桥样肝纤维化(>S3)。 4)停药前Fibroscan 提示有明显的肝纤维化或肝硬化。 5)合并有其它病毒感染,包括有HCV、HDV、HIV、自身免疫性肝病等。 6)合并其他任何严重的或活动性的疾病,包括任何未被控制的具有临床意义的肾脏、心脏、肺脏、血管性、神经性、消化性、代谢性疾病(如糖尿病、甲状腺疾病和肾上腺疾病)、免疫缺陷疾病或癌症。 7)接受过肝移植的患者或计划进行肝移植的患者。 

Exclusion criteria:

Patientss who met any of the following criteria will not be eligible to this study; 1. The researchers consided that the patient could not comply with the study; 2. Patients with decompensated liver disease; 3. Patients with liver cirrhosis; 4. Patients with other viruses coninfection, such as HCV, HDV, HIV and autoimmune liver disease; 5. Patients with autoimmune diseases, cancer, other important organ dysfunctions and other serious complications; 6. Patients who had a liver transplant or plan to receive liver transplantation. 

研究实施时间:

Study execute time:

From2012-12-01To 2021-12-01 

征募观察对象时间:

Recruiting time:

From2012-12-01To 2018-12-01 

干预措施:

Interventions:

组别:

Case series

样本量:

176

Group:

Case series

Sample size:

干预措施:

长期核苷(酸)类药物治疗后

干预措施代码:

Intervention:

After long-term nucleoside (acid) treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医院 

单位级别:

三甲 

Institution
hospital:

Nanfang hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学第三附属医院 

单位级别:

三甲 

Institution
hospital:

Third Affiliated Hospital of Southern Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

病毒学指标

指标类型:

主要指标 

Outcome:

virological response

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化学指标

指标类型:

主要指标 

Outcome:

biochemical response

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清学指标

指标类型:

主要指标 

Outcome:

serological response

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

使用后保存 

说明

Fate of sample:

Preservation 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 18 years
最大 Max age 60 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):

由病人是否发生临床复发决定组别

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

The group is determined by whether the patient has a clinical relapse after stopping treatment.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

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):

通过ResMan提供原始数据查询

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

IPD will be public accessable via ResMan

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-15
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