今天是:2019-06-18 星期二

一项使用艾曲泊帕治疗慢性免疫性血小板减少症患者的IV期、多中心、观察性研究(CITE研究)
下载XML文档

注册号:

Registration number:

ChiCTR1900021755 

最近更新日期:

Date of Last Refreshed on:

2019-03-08 

注册时间:

Date of Registration:

2019-03-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项使用艾曲泊帕治疗慢性免疫性血小板减少症患者的IV期、多中心、观察性研究(CITE研究) 

Public title:

A Phase IV multicenter, observational study in Chronic Immune Thrombocytopenia patients on Eltrombopag treatment in emerging markets 

注册题目简写:

CITE研究 

English Acronym:

CITE study 

研究课题的正式科学名称:

一项使用艾曲泊帕治疗慢性免疫性血小板减少症患者的IV期、多中心、观察性研究(CITE研究) 

Scientific title:

A Phase IV multicenter, observational study in Chronic Immune Thrombocytopenia patients on Eltrombopag treatment in emerging markets 

研究课题代号(代码):

Study subject ID:

CETB115BIC02 

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:

解加密 

研究负责人:

常春康 

Applicant:

Jiami Xie 

Study leader:

Chunkang Chang 

申请注册联系人电话:

Applicant telephone:

+86 18401511854 

研究负责人电话:

Study leader's telephone:

+86 18930177640 

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:

xie.jiami@novartis.com 

研究负责人电子邮件:

Study leader's E-mail:

changchunkang@sina.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:

北京市朝阳区建国门外大街1号国贸写字楼2座12层 

研究负责人通讯地址:

上海市宜山路600号 

Applicant address:

12F, China World Tower 2, 1 Jianguomen Avenue, Chaoyang District, Beijing, China 

Study leader's address:

600 Yishan Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

100020 

研究负责人邮政编码:

Study leader's postcode:

200233 

申请人所在单位:

诺华(中国)生物医学研究有限公司 

Applicant's institution:

Novartis Institutes Biomedical Research Co.Ltd 

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:

2019-001 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Sixth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-31 

伦理委员会联系人:

孙老师 

Contact Name of the ethic committee:

Mr. Sun 

伦理委员会联系地址:

上海市徐汇区宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Xuhui Distract, Shanghai, 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:

上海市第六人民医院 

Primary sponsor:

Shanghai Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

瑞士

省(直辖市):

巴塞尔

市(区县):

Country:

Switzerland

Province:

Basel

City:

单位(医院):

诺华(中国)生物医学研究有限公司

具体地址:

上海市浦东新区张江高科技园区金科路4218号

Institution
hospital:

Novartis Institutes Biomedical Research Co.Ltd

Address:

4218 Jinke Road, Zhangjiang High Tech Park, Pudong New Area, Shanghai

经费或物资来源:

诺华(中国)生物医学研究有限公司 

Source(s) of funding:

Novartis Institutes Biomedical Research Co.Ltd 

研究疾病:

慢性免疫性血小板减少症 

Target disease:

Chronic Immune Thrombocytopenia 

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:

IV期临床试验 

Study phase:

研究目的:

1. 主要目的:治疗持续时间;患者依从性;有效性; 2. 次要目的:cITP 的治疗原则和艾曲泊帕在临床实践中的应用;生活质量:疲劳;艾曲泊帕治疗的安全性和耐受性; 3. 探索性目的:评估治疗持续时间依从性和结局的相关性;评估患者支持材料对患者依从性和治疗持续时间的影响。 

Objectives of Study:

1. Primary Objectives: Treatment duration; Adherence of patients; Efficacy; 2. Secondary objectives: Treatment algorithm in cITP and utilization of eltrombopag in clinical practice; QoL: fatigue; Safety and tolerability with eltrombopag treatment; 3. Exploratory objectives: To assess the correlation of adherence to treatment duration and outcome; To evaluate the impact of patient support material on patient adherence and treatment duration 

药物成份或治疗方案详述:

纳入患者后,会要求医生提供艾曲泊帕治疗期间的记录,直至最长的18 个月,或者至停药和停药后3 个月。总而言之,治疗的最长观察期为18 个月。应在常规访视时进行记录,大约为下列时间点:基线,1、3、6、12 和18 个月。 将对永久停用艾曲泊帕治疗的患者进行随访,直至停药后3 个月(但是不超过入组后的18 个月研究期)。永久停用的定义为停用艾曲泊帕≥3 个月。患者永久停药的定义是停止艾曲泊帕治疗≥3 个月。停用艾曲泊帕小于3 个月且没有接受任何新cITP 治疗或增加ITP 伴随用药的患者将自动被认为不是永久停用艾曲泊帕,可继续进行研究。 

Description for medicine or protocol of treatment in detail:

After inclusion of the patient, the physician is asked to provide documentation during treatment with eltrombopag until a maximum of 18 months, or until treatment discontinuation, and 3 months following discontinuation. Summarizing the above, there will be a maximum observational period of 18 month on treatment. Visits should be documented around routine visits and approximately at the following time points: Baseline, and 1, 3, 6, 12, and 18 months. Patients who permanently discontinue eltrombopag treatment will be followed up for up to 3 months after discontinuation (but not exceeding a study period of 18 months after enrollment). Permanent discontinuation is defined as stopping eltrombopag treatment for ≥ 3months. Patients who stop eltrombopag for less than 3 months without receiving any new cITP treatment or dose increase for concomitant ITP medication are not automatically considered to have permanently discontinued eltrombopag and may continue on the study. 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

主要入选标准: 1. 患者被诊断为免疫性血小板减少症,并且根据该国的上市许可和研究者判断,有资格接受Revolade?[土耳其:艾曲泊帕]治疗; 2. 开始艾曲泊帕治疗的 cITP 患者(在研究入组前12 周内开始目前治疗周期的患者也是有资格的)允许以前停止艾曲泊帕治疗周期,只要上一个周期的末次给药和CITE 研究相关疗程内首次给药的间隔至少为12 周; 3. 既往使用罗米司亭治疗是允许的; 4. 成年的男性或女性,≥18 岁; 5. 获取书面知情同意书。 

Inclusion criteria

Main Inclusion criteria: 1. Patients diagnosed with immune thrombocytopenia and eligible for Revolade [Turkey: eltrombopag] treatment according to the market authorization in the country and the investigators judgement; 2. cITP patients startingon eltrombopag treatment (patients who started treatment in the current treatment cycle up to 12 weeks prior to study enrollment are also eligible);Previous discontinued treatment cycles of eltrombopag are permitted as long as the time period between the last dose in the previous cycle and the first dose within the CITE study-relevant course is at least 12 weeks; 3. Prior treatment with romiplostim is allowed; 4. Male or female, adults ≥ 18 years; 5. Written informed consent. 

排除标准:

主要排除标准: 1. 当地上市许可/药品说明书中所列的任何禁忌症 2. 正处于酗酒或药物成瘾的患者,这会影响其遵循研究要求的能力 3. 根据研究者的观点,因为任何原因而不太可能获得长期随访信息的患者,例如联系不到或者有严重的伴随疾病; 4. 患者在本项临床研究开始时参加了任何一项干预临床试验; 5. 对于 ITP 适应症,CITE 以外的非干预研究也要被排除; 6. 本项非干预研究将不会纳入儿科ITP 患者(<18 岁); 7. 艾曲泊帕的其他适应症:治疗血小板减少症的慢性丙型肝炎病毒(HCV)感染患者或者重度再生障碍性贫血(SAA)患者均不在本研究的范围内,并且将不被纳入本非干预研究。 

Exclusion criteria:

Main Exclusion Criteria: 1. Any contraindication listed in the local market authorization/SmPC; 2. Patients with active alcohol or drug addiction that would interfere with their ability; 3. According to the investigators opinion, the patient is an unlikely candidate to obtain longterm follow-up information for any reasons such as unavailability or severe concomitant illnesses; 4. Patients participating in any interventional clinical trial at start of this clinical study; 5. For the indication of ITP also non-interventional studies other than CITE are excluded; 6. No pediatric ITP patients (<18 years) will be included into this NIS; 7. Other indications for eltrombopag such as for patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, or Severe Aplastic Anemia (SAA) are not in scope and will not be enrolled in this NIS. 

研究实施时间:

Study execute time:

From2018-10-01To 2022-06-01 

干预措施:

Interventions:

组别:

单臂研究

样本量:

100

Group:

Single Arm

Sample size:

干预措施:

艾曲泊帕

干预措施代码:

Intervention:

eltrombopag treatment

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):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市第六人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

治疗持续时间和依从性

指标类型:

主要指标 

Outcome:

Treatment duration and adherence

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效(血液学和临床)

指标类型:

主要指标 

Outcome:

Efficacy (hematological and clinical)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

cITP 的治疗原则和使用

指标类型:

次要指标 

Outcome:

Treatment algorithm in cITP and Utilization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量:疲劳

指标类型:

次要指标 

Outcome:

Quality of life: fatigue

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性和耐受性

指标类型:

次要指标 

Outcome:

Safety and tolerability

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:

数据信息

组织:

Sample Name:

Data information

Tissue:

人体标本去向

其它 

说明

出口出境

Fate of sample:

Others 

Note:

Export exit

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 无限制 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):

非随机

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

Non randomized

盲法:

NA

Blinding:

NA

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):

上海市第六人民医院血液科,随时查阅

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

Department of Hematology, Shanghai Sixth People's Hospital;consult any time

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:

原始临床病例资料保存

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

Preservation of original clinical case data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-03-08
返回列表