今天是:2019-06-17 星期一

干扰素α1b治疗儿童慢性乙型肝炎的临床合理用药研究
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注册号:

Registration number:

ChiCTR1900020668 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

干扰素α1b治疗儿童慢性乙型肝炎的临床合理用药研究 

Public title:

Study for the Clinical Rational Drug Use of Interferon α1b Therapy in Children with Chronic Hepatitis B 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

干扰素α1b治疗儿童慢性乙型肝炎的临床合理用药研究 

Scientific title:

Study for the Clinical Rational Drug Use of Interferon α1b Therapy in Children with Chronic Hepatitis B 

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:

毕京峰 

研究负责人:

毕京峰 

Applicant:

Jingfeng Bi 

Study leader:

Jingfeng Bi 

申请注册联系人电话:

Applicant telephone:

+86 18911809369 

研究负责人电话:

Study leader's telephone:

+86 18911809369 

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:

123bjf@163.com 

研究负责人电子邮件:

Study leader's E-mail:

123bjf@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:

中国北京西四环中路100号 

研究负责人通讯地址:

中国北京西四环中路100号 

Applicant address:

100 Sihuan Middle Road West, Beijing, China 

Study leader's address:

100 Sihuan Middle Road West, Beijing, 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:

中国人民解放军第三〇二医院 

Applicant's institution:

302 Hospital of the Chinese People's Liberation Army 

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:

2018113D 

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:

中国人民解放军第三〇二医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the 302 Hospital of the Chinese People's Liberation Army 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-05 

伦理委员会联系人:

于峰 

Contact Name of the ethic committee:

Feng Yu 

伦理委员会联系地址:

中国北京西四环中路100号 

Contact Address of the ethic committee:

100 Sihuan Middle Road West, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010 66933461 

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:

中国人民解放军第三〇二医院 

Primary sponsor:

302 Hospital of the Chinese People's Liberation Army 

研究实施负责(组长)单位地址:

中国北京西四环中路100号 

Primary sponsor's address:

100 Sihuan Middle Road West, 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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军第三〇二医院

具体地址:

中国北京西四环中路100号

Institution
hospital:

302 Hospital of the Chinese People's Liberation Army

Address:

100 Sihuan Middle Road West, Beijing, China

经费或物资来源:

首都卫生发展科研专项 

Source(s) of funding:

Capital Health Development Research Project 

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:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过建立IFN α1b 治疗儿童CHB患者的群体药动学/药效学模型,阐明IFN治疗儿童CHB患者的分子-生理-病理-药代动力学-药效动力学内在量效关系,实现定量考察个体患者的药动学/药效学参数,从而优化IFN治疗儿童CHB个体化给药方案,指导临床合理用药是本课题的研究目标。 

Objectives of Study:

To establish a population pharmacokinetic/pharmacodynamic model of IFN α1b in children with CHB, and to elucidate the molecular-physiological-pathological-pharmacokinetic-pharmacodynamic intrinsic dose-effect relationship of IFN in children with CHB, achieve quantitative investigation of the pharmacokinetic/pharmacodynamic parameters of individual patients, optimizing the individualized administration of CHB in children with IFN treatment, and guiding clinical rational drug use. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

① 符合欧洲“2013 ESPGHAN 儿童时期慢性乙型肝炎的诊治指南”儿童慢性乙型肝炎诊断标准及IFN治疗指征; ② 即将或正在接受IFN α1b的患者; ③ 1岁≤年龄≤16岁,男女不限; ④ 从本次应用干扰素治疗前3个月至目前为止,未接受过其他抗病毒药物治疗者; ⑤ 同意签署知情同意书者(1-6岁患儿可由监护人签字;7岁-11岁患儿原则上由患儿与监护人一起签字;12岁以上必须由患儿与监护人一起签字)。 

Inclusion criteria

1. The diagnostic criteria for chronic hepatitis B and the indications for IFN treatment in children are in line with the European 2013 ESPGHAN Guidelines for the Diagnosis and Treatment of Chronic Hepatitis B in Children; 2. patients who are about to accept or are undergoing IFN α1b; 3. 1 year old ≤ age ≤ 16 years old, male or female; 4. From the 3 months before the application of interferon therapy, no other antiviral drugs have been treated; 5. Agree to sign the Informed Consent Form (Children aged 1-6 years may be signed by the guardian; children between the ages of 7 and 11 are in principle signed by the child and the guardian; those over the age of 12 must be signed by the child and the guardian). 

排除标准:

① 合并HCV、HDV或HIV感染者; ② 正在接受其他可能影响IFN药动学或药效学的药物治疗者; ③ 合并脑部重大疾病、严重心脏病等重要系统、器官等的重大疾病者; ④ 合并智力异常、痴呆者; ⑤ 合并有精神病者; ⑥ 研究医生认为不适宜参与本研究者。 

Exclusion criteria:

1. Combined with HCV, HDV or HIV-infected persons; 2. Receiving other medical treatments that may affect the pharmacokinetics or pharmacodynamics of IFN; 3. Those who have major diseases such as serious heart or brain diseases; 4. Combined with mental abnormalities, such as dementia; 5. Merged with mentally ill persons; 6. The research doctor considered it inappropriate to participate in the study. 

研究实施时间:

Study execute time:

From2019-01-10To 2020-12-31 

干预措施:

Interventions:

组别:

无组别

样本量:

150

Group:

Case series

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):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军第三〇二医院 

单位级别:

三级甲等 

Institution
hospital:

302 Hospital of the Chinese People's Liberation Army  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

IFN α1b血清药物浓度

指标类型:

主要指标 

Outcome:

IFN α1b serum drug concentration

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

保存2年

Fate of sample:

Preservation after use 

Note:

Cryopreservation for 2 years

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 1 years
最大 Max age 16 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):

没有采取随机措施

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

No random

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):

由北京市卫生局公开原始数据

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

Open raw data by the Beijing Municipal Health Bureau

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:

首先采用纸质CRF采集数据,然后构建EDC数据库进行电子信息存储与管理

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

First, collect data using paper CRF, and then build an EDC database for electronic information storage and management.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-12
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