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应用替比夫定抗病毒治疗对乙肝相关肝癌患者术后乙肝病毒再激活及预后影响的随机对照临床研究
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注册号:

Registration number:

ChiCTR-IPR-15006587 

最近更新日期:

Date of Last Refreshed on:

2015-06-16 

注册时间:

Date of Registration:

2015-05-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

应用替比夫定抗病毒治疗对乙肝相关肝癌患者术后乙肝病毒再激活及预后影响的随机对照临床研究 

Public title:

A randomized controlled trial:Evaluating the impact of telbivudine treatment on the prognosis of HBV-related liver cancer and posthepatectomy HBV reactivation in hepatitis B-related hepatocellular carcinoma. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用替比夫定抗病毒治疗对乙肝相关肝癌患者术后乙肝病毒再激活及预后影响的随机对照临床研究 

Scientific title:

A randomized controlled trial:Evaluating the impact of telbivudine treatment on the prognosis of HBV-related liver cancer and posthepatectomy HBV reactivation in hepatitis B-related hepatocellular carcinoma. 

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:

黄罡 

研究负责人:

周伟平 

Applicant:

Gang Huang 

Study leader:

Weiping Zhou 

申请注册联系人电话:

Applicant telephone:

+86 13918663457 

研究负责人电话:

Study leader's telephone:

+86 13601616763 

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:

squaror@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

ehphwp@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:

上海市杨浦区长海路255号东方肝胆外科医院 

研究负责人通讯地址:

上海市杨浦区长海路255号东方肝胆外科医院 

Applicant address:

255 Changhai road, Yangpu district, Shanghai, China 

Study leader's address:

255 Changhai road, Yangpu district, Shanghai, 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:

第二军医大学东方肝胆外科医院 

Applicant's institution:

Eastern Hepatobiliary Surgical 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:

EHBHKY2008-04-007 

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:

上海东方肝胆外科医院临床研究伦理委员会 

Name of the ethic committee:

Verification of Clinical Research Ethics Committee, Eastern Hepatobiliary Surgery Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

第二军医大学东肝肝胆外科医院 

Primary sponsor:

Eastern Hepatobiliary Surgical hospital 

研究实施负责(组长)单位地址:

上海市杨浦区长海路255号 

Primary sponsor's address:

255 Changhai road, Yangpu district, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

第二军医大学东肝肝胆外科医院

具体地址:

上海市杨浦区长海路255号

Institution
hospital:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Address:

Eastern Hepatobiliary Surgical hospital, No.255, Changhai road, Yangpu district, Shanghai

经费或物资来源:

东方肝胆外科医院和上海市科委支持 

Source(s) of funding:

Eastern Hepatobiliary Surgery Hospital and the Shanghai Science and Technology Commission Research Fund 

研究疾病:

乙肝相关肝癌 

Target disease:

hepatitis B-related hepatocellular carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

Post-market 

研究目的:

本研究的目的是对应用替比夫定抗病毒治疗预防肝癌患者术后乙肝病毒再激活的有效性进行评价。 

Objectives of Study:

A randomized controlled trial was carried out to evaluate the effectiveness of the impact of having telbivudine after operatin or not on posthepatectomy HBV reactivation. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1. age 18 to 70 years; 2. positive test for Hepatitis B surface antigen (HBsAg) and negative test for antibody to hepatitis C virus (HCV-Ab) or human immunodeficiency virus; 3. serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000 IU/ml; 4. Barcelona Clinic Liver Cancer (BCLA) stage 0, A or a solitary tumor with diameter> 5cm; 5. no extrahepatic metastasis; 6. no radiologic evidence of invasion into major portal/hepatic venous branches; 7. good liver function with Child - Pugh Class A and baseline serum alanine aminotransferase (ALT) level< 2 times the upper limit of normal (reference range<40 IU/L), with no history of encephalopathy, ascites refractory to diuretics, esophago-gastric variceal bleeding; 8. good renal function(a serum creatinine level < 133 umol/L); 9. no previous treatment for hepatitis B with nucleoside or nucleotide analogues or both; 10. no treatment with interferon or other immunomodulators within the previous 12 months; 11. a serum amylase or lipase level lower than 1.5 times the upper limit of normal; 12. no previous treatment of HCC; 13. negative resection margin (R0 resection); 14. histopathological result of the resected specimens being HCC. Eligible patients were excluded if they refused to participate. 

Inclusion criteria

1. age 18 to 70 years; 2. positive test for Hepatitis B surface antigen (HBsAg) and negative test for antibody to hepatitis C virus (HCV-Ab) or human immunodeficiency virus; 3. serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000 IU/ml; 4. Barcelona Clinic Liver Cancer (BCLA) stage 0, A or a solitary tumor with diameter> 5cm; 5. no extrahepatic metastasis; 6. no radiologic evidence of invasion into major portal/hepatic venous branches; 7. good liver function with Child - Pugh Class A and baseline serum alanine aminotransferase (ALT) level< 2 times the upper limit of normal (reference range<40 IU/L), with no history of encephalopathy, ascites refractory to diuretics, esophago-gastric variceal bleeding; 8. good renal function(a serum creatinine level < 133 umol/L); 9. no previous treatment for hepatitis B with nucleoside or nucleotide analogues or both; 10. no treatment with interferon or other immunomodulators within the previous 12 months; 11. a serum amylase or lipase level lower than 1.5 times the upper limit of normal; 12. no previous treatment of HCC; 13. negative resection margin (R0 resection); 14. histopathological result of the resected specimens being HCC. Eligible patients were excluded if they refused to participate. 

排除标准:

拒绝参加者 

Exclusion criteria:

patients were excluded if they refused to participate or they are not eligible. 

研究实施时间:

Study execute time:

From2008-11-01To 2015-03-31 

干预措施:

Interventions:

组别:

A

样本量:

100

Group:

A

Sample size:

干预措施:

替比夫定

干预措施代码:

Intervention:

telbivudine

Intervention code:

组别:

B

样本量:

100

Group:

B

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

CHina 

Province:

Shanghai 

City:

 

单位(医院):

第二军医大学东方肝胆外科医院 

单位级别:

三甲医院 

Institution
hospital:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

乙肝病毒在激活发生率

指标类型:

主要指标 

Outcome:

rate of HBV reactivationon

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤复发率

指标类型:

主要指标 

Outcome:

Rate of tumor recurrence

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存率

指标类型:

主要指标 

Outcome:

survival rate

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:

血清

组织:

Sample Name:

serum

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 18 years
最大 Max age 70 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):

计算机生成随机号

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

computer generate randomization number

盲法:

Blinding:

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):

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:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-05-26
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