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替比夫定阻断妊娠早、中期HBV孕妇母婴传播
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注册号:

Registration number:

ChiCTR-OPC-16007899 

最近更新日期:

Date of Last Refreshed on:

2016-02-05 

注册时间:

Date of Registration:

2016-01-25 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

替比夫定阻断妊娠早、中期HBV孕妇母婴传播 

Public title:

Telbivudine to prevent mother-to-infant transmission of HBV in early and mid pregnancy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

替比夫定阻断妊娠早、中期HBV孕妇母婴传播 

Scientific title:

Telbivudine to prevent mother-to-infant transmission of HBV in early and mid pregnancy 

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:

孙维会 

研究负责人:

孙维会 

Applicant:

SUN WH 

Study leader:

SUN WH 

申请注册联系人电话:

Applicant telephone:

+86 13396399678 

研究负责人电话:

Study leader's telephone:

+86 13396399678 

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:

sunty2009@126.com 

研究负责人电子邮件:

Study leader's E-mail:

sunty2009@126.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:

山东青岛城阳人民医院 长城路600号 

研究负责人通讯地址:

山东青岛城阳人民医院 长城路600号 

Applicant address:

600 Great wall Road, Qingdao, Shandong, China 

Study leader's address:

600 Great wall Road, Qingdao, Shandong, 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:

青岛城阳人民医院 

Applicant's institution:

Chengyang people's Hospital of Qingdao 

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:

201305 

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:

青岛市城阳人民医院伦理委员会 

Name of the ethic committee:

the Ethics Committee of The Chengyang people's Hospital of Qingdao 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-09 

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:

青岛城阳人民医院 

Primary sponsor:

Qingdao Chengyang People's Hospital 

研究实施负责(组长)单位地址:

山东青岛城阳人民医院 长城路600号 

Primary sponsor's address:

600 Great wall Road, Qingdao, Shandong, 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):

山东省

市(区县):

青岛市

Country:

China

Province:

Shandong

City:

Qingdao

单位(医院):

城阳区人民医院

具体地址:

山东青岛城阳人民医院 长城路600号

Institution
hospital:

Qingdao Chengyang People’s Hospital

Address:

600 Great wall Road, Qingdao, Shandong, China

经费或物资来源:

城阳区科研基金 

Source(s) of funding:

the Research Foundation of the Chengyang District 

研究疾病:

乙型病毒型肝炎 

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:

评价妊娠早、中期应用替比夫定阻断高病毒载量孕妇母婴传播的疗效和安全性 

Objectives of Study:

To evaluate the efficacy and safety of telbivudine in preventing mother-to-infant transmission of HBV in early and mid pregnancy. 

药物成份或治疗方案详述:

替比夫定 

Description for medicine or protocol of treatment in detail:

telbivudine 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)年龄在20-35岁;(2)孕12周;(3)患者血清HBsAg阳性,HBeAg阳性,且持续时间大于6个月,HBV-DNA>1×l07拷贝/ml;(4)肝功能异常:谷丙转氨酶(ALT)40U/L~400U/L(ALT正常值﹤40U/L);(5)具有良好的依从性。 

Inclusion criteria

1. aged 20 to 35 years; 2. 12 weeks or 20-28 weeks of gestation; 3. patients with HBsAg-positive, HBeAg-positive, HBV DNA >=1.0*10^7 copies/ml; 4. alanine aminotransferase (ALT): 40 to 400 U/L; 5. good compliance. 

排除标准:

(1)孕期合并其他感染:抗-HCV阳性、人类免疫缺陷病毒抗体阳性、梅毒快速血浆反应素环状卡片试验阳性,以及弓形虫、风疹病毒、巨细胞病毒、单纯疱疹病毒感染阳性;(2)孕期使用过其他抗病毒药物、免疫抑制剂、细胞毒性药物及皮质激素类药物。(3)B超提示胎儿畸形。(4)其他遗传性疾病史,孕早期有先兆流产,保胎等病史;(5)无妊娠糖尿病、严重呼吸、泌尿、神经系统病史及合并严重消化道疾病影响药物吸收者。(6)丈夫系HBV感染者。 

Exclusion criteria:

1. coinfection with other viruses during pregnancy: such as hepatitis A, C, D, E, human immunodeficiency virus, syphilis, toxoplasma gondii, rubella virus, cytomegalovirus, or simple herpesvirus infection; 2. The use of other antiviral drugs, immunosuppressive, cytotoxic drugs or corticosteroids during pregnancy ; 3. fetal deformity suggested by ultrasound examination; 4. genetic diseases; 5. gestational diabetes; serious respiratory, urinary, neurological comorbidity or combined with serious gastrointestinal diseases which affect drug absorption. 

研究实施时间:

Study execute time:

From2013-01-01To 2015-06-01 

征募观察对象时间:

Recruiting time:

From2009-01-01To 2013-01-01 

干预措施:

Interventions:

组别:

A组

样本量:

62

Group:

Group A

Sample size:

干预措施:

孕12周给予替比夫定抗病毒治疗,产后12周停药

干预措施代码:

Intervention:

treated with telbivudine from12 weeks of gestation,Telbivudine was discontinued at postpartum 12 weeks.

Intervention code:

组别:

B组

样本量:

61

Group:

group B

Sample size:

干预措施:

孕20-28周给予替比夫定抗病毒治疗,并于产后12周停药

干预措施代码:

Intervention:

treated with telbivudine from20 to 28 weeks of gestation,Telbivudine was discontinued at postpartum 12 weeks.

Intervention code:

组别:

C组

样本量:

65

Group:

Group C

Sample size:

干预措施:

未给予替比夫定抗病毒治疗

干预措施代码:

Intervention:

wasn’t given telbivudine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

青岛市 

Country:

China 

Province:

Shandong 

City:

Qingdao 

单位(医院):

青岛城阳人民医院 

单位级别:

二级甲等 

Institution
hospital:

Chengyang people's Hospital of Qingdao.  

Level of the institution:

Secondary A hospital 

测量指标:

Outcomes:

指标中文名:

血清HBVDNA载量

指标类型:

主要指标 

Outcome:

serum levels of HBV DNA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

主要指标 

Outcome:

ALT level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HBsAg 阳性率

指标类型:

主要指标 

Outcome:

HBsAg positive 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:

孕妇年龄

指标类型:

次要指标 

Outcome:

the age of pregnant women

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孕妇病史

指标类型:

次要指标 

Outcome:

the disease duration years of pregnant women

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孕妇的分娩时间与孕龄

指标类型:

次要指标 

Outcome:

the gravidity times and gestational of pregnent women

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胎龄

指标类型:

主要指标 

Outcome:

gestational age

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体质量

指标类型:

主要指标 

Outcome:

body weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头围

指标类型:

主要指标 

Outcome:

head circumference

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Apgar 评分

指标类型:

主要指标 

Outcome:

Apgar score

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 35 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):

乙肝孕妇根据个人意愿分组

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

Those pregnant women with HBV were divided into three groups on voluntary basis.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

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

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:

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

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:

 2016-01-25
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