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A Prospective Cohort Study on Drug-induced Liver Injury in China(DILI-P) (DILI-P)

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ClinicalTrials.gov Identifier: NCT02961413
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Drug Induced Liver Disease Study Group

Brief Summary:

This is a multi-center, prospective, non-interventional cohort study .

Its primary objectives are:

  1. assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;
  2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Condition or disease
Drug-induced Liver Injury

Detailed Description:

The main purpose of this study is to understand patients with DILI clinical outcome and influencing factors in China's second and tertiary general hospitals (including Western medicine hospital, Chinese medicine hospital andIntegrated traditional Chinese and Western Medicine Hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, Pulmonary, etc.) in mainland.

The main purpose

  1. assess the DILI patients' clinical outcomes and influencing factors in the real world;
  2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Secondary objectives

  1. assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.;
  2. evaluate the histological features of DILI patients;
  3. assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
cohort 1
Compound glycyrrhizin tablets / injection
cohort 2
Isoglycyrrhizinate magnesium injection / diammonium glycyrrhizinate enteric-coated capsules
cohort 3
Bicyclol
cohort 4
Silibinin capsules
cohort 5
Ursodeoxycholic acid capsules
cohort 6
N- acetylcysteine



Primary Outcome Measures :
  1. Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
serum, plasma, histology, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients with drug-induced liver injury
Criteria

Inclusion Criteria:

  • Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines
  • RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury
  • patient can provide informed consent form

Exclusion Criteria:

  • non-drug-induced liver injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961413


Contacts
Contact: Ling Ru ling.ru@unimedsci.com

Locations
China
Renji hospital Recruiting
Shanghai, China
Contact: Yimin Mao         
Sponsors and Collaborators
Drug Induced Liver Disease Study Group
Investigators
Study Chair: Yimin Mao RenJi Hospital
Study Chair: Chengwei Chen No.85 Hospital of PLA
Principal Investigator: Xingfang Li Pulmonary Hospital of Lanzhou
Principal Investigator: Yiling Li First Hospital of China Medical University
Principal Investigator: Dongliang Li Fuzhou General Hospital
Principal Investigator: Suocai Zhang Changzhou Third People 's Hospital
Principal Investigator: Rongxia Sang First Hospital of Shijiazhuang City
Principal Investigator: Zhihui Li Hebei Chest Hospital
Principal Investigator: Feng Sun First Affiliated Hospital of Heilongjiang Chinese Medicine University
Principal Investigator: Wushu Yan Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Principal Investigator: Yanqin Wu Bazhou People 's Hospital
Principal Investigator: Xu Lian Mudanjiang Red Flag Hospital
Principal Investigator: Mingfang Wang Pingdingshan People's Hospital No.1
Principal Investigator: Yanrong Shi General Hospital of Pingdingshan Coal Industry Company
Principal Investigator: Hongwei Chen Luoyang Central Hospital
Principal Investigator: Ximei Wang Third Hospital Affiliated to Henan University of Science and Technology
Principal Investigator: Hongling Liu The First People's Hospital of Luoyang
Principal Investigator: Renping Li The Second Hospital Affiliated to Henan University of Science and Technology
Principal Investigator: Zhengsheng Zou Beijing 302 Hospital
Principal Investigator: Jiguang Ding Ruian People's Hospital
Principal Investigator: Yanjun Guo Daqing oilfield general hospital
Principal Investigator: Weixin He The No.123 Hospital of Chinese People's Liberation Army
Principal Investigator: Wufang Qi Tianjin First Central Hospital
Principal Investigator: Yuqin Xu The No.211 Hospital of Chinese People's Liberation Army
Principal Investigator: Jing Zhang Beijin Youan Hospital,Capital Medical University
Principal Investigator: Peilan Zong Jiangxi Chest Hospital
Principal Investigator: Yuefei Shen The First People's Hospital of Hangzhou Xiaoshan District
Principal Investigator: Chunyan Zhou Infectious Diseases Hospital of Shangqiu
Principal Investigator: Baijing Ding The Second People's Hospital of Wuhu
Principal Investigator: Liyun Chen Wuhu Third People's Hospital
Principal Investigator: Yongze Guo Affiliated Hospital of Hebei University of Engineering
Principal Investigator: Haibin Wang Fifth Hospital of Shijiazhuang City
Principal Investigator: Hui Guo First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Principal Investigator: Hongling Liu Beijing 302 Hospital
Principal Investigator: Yingjian Zhang The First Affiliated Hospital of Henan University of Science and Technology
Principal Investigator: Qing Mao Southwest Hospital, China
Principal Investigator: Liaoyun Zhang First Hospital of Shanxi Medical University
Principal Investigator: Jiawei Gen First People's Hospital of Yunnan Province
Principal Investigator: Weize Zuo The First Affiliated Hospital of Medical College,Shihezi University
Principal Investigator: Xia Zhang Nanjing Chest Hospital
Principal Investigator: Xuan Zhu The First Affiliated Hospital of Nanchang University
Principal Investigator: Feng Shuai Linyi People's Hospital
Principal Investigator: Kunyun Yang Hunan Chest Hospital
Principal Investigator: Chuanwu Zhu The Fifth People,Hospital of Suzhou
Principal Investigator: Wei Ge Renmin Hospital of Wuhan University
Principal Investigator: Xiaojin Wang 85 Hospital of People's Liberation Army
Principal Investigator: Jiajun Liu The First Affiliated Hospital of Xiamen University
Principal Investigator: Yan Huang Xiangya Hospital of Central South University
Principal Investigator: Fangping He First Affiliated Hospital of Xinjiang Medical University
Principal Investigator: Xinmin Zhou Xijing Hospital
Principal Investigator: Aiqing Lin The First Affiliated Hospital of Inner Mongolia University of Science and Technology
Principal Investigator: Xiaojing Jiang Wuhan General Hospital of Guangzhou Military
Principal Investigator: Qing Xie Ruijin Hospital
Principal Investigator: Qingge Zhang Xingtai People's Hospital
Principal Investigator: Yanyan Yu Peking University First Hospital
Principal Investigator: Jing Yuan Shenzhen Third People's Hospital
Principal Investigator: Shiwu Ma Kunming General Hospital of Chengdu Military Area Command
Principal Investigator: Jun Chen Central South University
Principal Investigator: Qinghua Yao Zhejiang Cancer Hospital
Principal Investigator: Yihong Zhang The No.457 Hospital of Chinese People's Liberation Army
Principal Investigator: Qi Wang Second Hospital of Shanxi Medical University
Principal Investigator: Xiaozhong Wang Xinjiang Autonomous Region Hospital of TCM
Principal Investigator: Yongwen Ma Daqing Longnan Hopital
Principal Investigator: Fangfang Lv Sir Run Run Shaw Hospital
Principal Investigator: Xiaojun Zhang Ankang City Central Hospital
Principal Investigator: Riwang Hu The Fouth People's Hospital of Datong
Principal Investigator: Yi Song Chongqing Traditional Chinese Medicine Hospital
Principal Investigator: Peng Hu The Second Affiliated Hospital of Chongqing Medical University
Principal Investigator: Wen Xie Beijing Ditan Hospital
Principal Investigator: Yongguo Li First Affiliated Hospital of Harbin Medical University
Principal Investigator: Haiyan Jin Yanbian University Hospital
Principal Investigator: Zheng Li The First People's Hospital of Qinzhou
Principal Investigator: Shuixiang He First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator: Lei Li Anhui Provincial Hospital
Principal Investigator: Junqi Niu The First Affiliated Hospital of Jilin University
Principal Investigator: Bin Jiang The Second People's Hospital of Liaoyuan
Principal Investigator: Jing You The First Affiliated Hospital of Kunming Medical College
Principal Investigator: Youqin Yan Wuhan NO.7 Hospital
Principal Investigator: Lvye Xv General Hospital of The Yangtze River Shipping
Principal Investigator: Changyong Zhang Wuhan Psychological Hospital
Principal Investigator: Guanghua Xv Ya'nan University Affiliated Hospital
Principal Investigator: Hongbin Li The First Affiliated Hospital of Anhui Medical University
Principal Investigator: Yongfeng Yang The Second Hospital of Nanjing
Principal Investigator: Xilian Dong Yuncheng Central Hospital
Principal Investigator: Xuefeng Su Linfen People's Hospital
Principal Investigator: Mudan Yang Shanxi Provincial Cancer Hospital
Principal Investigator: Zhen Ma The Affiliated Hospital of Inner Mongolia Medical University
Principal Investigator: Hong Tang West China Hospital
Principal Investigator: Chenghai Liu Shanghai Shuguang Hospital
Principal Investigator: Zhenyu Yan South China University of Science And Technology Affiliated Hospital
Principal Investigator: Fei Qiao Jiangsu province hospital of TCM
Principal Investigator: Xingxiang Yang Sichuan Province Hospital
Principal Investigator: Jinjun Chen Nanfang Hospital of Southern Medical University
Principal Investigator: Weihong Sha Guangdong General Hospital
Principal Investigator: Jie Jin First People's Hospital of Hangzhou
Principal Investigator: Feng Lin Hainan General Hospital
Principal Investigator: Guoqi Zheng Cangzhou Central Hospital
Principal Investigator: Jiyao Wang Zhong Shan Hospital
Principal Investigator: Lin Chen LanZhou University
Principal Investigator: Dongliang Yang Tongji Medical College of Huazhong University of Science and Technology
Principal Investigator: Li Chen The Center Hospital Of Maanshan
Principal Investigator: Guizhou Zou The Second Hospital of Anhui Medical University
Principal Investigator: Yong Wang Fuyang First People's Hospital
Principal Investigator: Lianqing Lou Yiwu Central Hospital
Principal Investigator: Huaming Li Hangzhou Third People's Hospital
Principal Investigator: Shifang Chen Huzhou Central Hospital
Principal Investigator: Zhifen Pan The First Hospital of Jiaxing
Principal Investigator: Wenlong Zheng Hangzhou Hospital of Traditional Chinese Medicine
Principal Investigator: Jingbo Pei Hangzhou Xiaoshan Hospital of Traditional Chinese Medicine
Principal Investigator: Feng Guo Hangzhou Xiaoshan First People's Hospital
Principal Investigator: Feng Qian Dongyang People's Hospital
Principal Investigator: Jianzheng Mao Zhejiang Quhua Hospital
Principal Investigator: Ahuo Ma Shaoxing People's Hospital
Principal Investigator: Qinhong Zheng People's Hospital of Quzhou
Principal Investigator: Jufen Xu Tongxiang First People's Hospital
Principal Investigator: Jiemin Hong Ningbo Yinzhou No.2 Hospital
Principal Investigator: Jianwei Shen Ningbo Medical Center Lihuili Eastern Hospital
Principal Investigator: Yunsong Qian Ningbo No.2 Hospital
Principal Investigator: Weihong Du Jinhua Central Hospital
Principal Investigator: Jiaxin Liu Huzhou Hospital of Traditional Chinese Medicine
Principal Investigator: Qingjing Ru Zhejiang Construction Hospital
Principal Investigator: Chunsheng Zhao The No.98 Hospital of Chinese People's Liberation Army
Principal Investigator: Yinxia Hao Baoding First Central Hospital
Principal Investigator: Li Sun Xi'an No.3 Hospital
Principal Investigator: Wenlei Hu Le Qin People's Hospital
Principal Investigator: Shuangsuo Dang Second Affiliated Hospital of Xi'an Jiaotong University
Principal Investigator: Yu Chen Zhengzhou No.6 People's Hospital
Principal Investigator: Zhaoxia Liu First Affiliated Hospital of Heilongjiang Chinese Medicine University
Principal Investigator: Yang Pan Heilongjiang Provincial Hospital of Traditional Chinese Medicine
Principal Investigator: Yi Shen Dandong City Infectious Disease Hospital
Principal Investigator: Xia Li Baoding City Infectious Disease Hospital
Principal Investigator: Qian Zhong Anshan Central Hospita
Principal Investigator: Zhixiong Fang Xiangtan Central Hospita
Principal Investigator: Xiaoping Xu Xiangxi Autonomous Prefecture People's Hospital
Principal Investigator: Sihai Li The First People's Hospital of Yueyang
Principal Investigator: Hui Tian The People's Hospital of Xuancheng City
Principal Investigator: Shiquan Ka The First People's Hospital of Lanzhou City
Principal Investigator: Dongfang Li Anhui Province Chest Hospital
Principal Investigator: Yuqiang Nie Guangzhou First People's Hospital
Principal Investigator: Yan Song Heilongjiang Mudanjiang Nanshan Hospital
Principal Investigator: Xiaoyan Guo Second Affiliated Hospital of Xi'an Jiaotong University
Principal Investigator: Caiyan Zhao Hebei Medical University Third Hospital
Principal Investigator: Yuemin Nan Hebei Medical University Third Hospital
Principal Investigator: Dingguo Wang People 's Hospital of Kaizhou District, Chongqing City
Principal Investigator: Li Wang Public Health Clinical Center of Chengdu
Principal Investigator: Lixin Tong First Hospital of Hebei Medical University
Principal Investigator: Hao Wu West China Hospital,Huaxi University
Principal Investigator: Shurui Piao Jinshan Hospital of Fudan University
Principal Investigator: Lvfeng Yao Meng Chao Liver and Gallbladder Hospital of Fujian Medical University
Principal Investigator: Yanqing Tian Affiliated Hospital of Hebei University

Responsible Party: Drug Induced Liver Disease Study Group
ClinicalTrials.gov Identifier: NCT02961413     History of Changes
Other Study ID Numbers: 2012ZX09303-002
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning