Drug-Induced Liver InjuryDILI-RNCT02407964
A Retrospective Study on Drug Induced Liver Injury in China
An observational study of Drug-Induced Liver Injury, run by Drug Induced Liver Disease Study Group at 371 sites in China.
Trial summary
This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-Induced Liver Injury
- How many people
- 15,000 participants
- Where
- 371 sitesChina
- Study dates
- Mar 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were hospitalized during 2012 to 2014.
Who may be able to join
- Any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
- The drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature.
Who cannot join
- Confirmed non-drug induced liver injury.
- Insufficient clinical data supporting the diagnosis of drug-induced liver injury.
- Liver injury resulted from poisons and chemicals.
Trial locations and contacts
371 sites in 1 country.
300 sites in 1 country
China300 sites
Department of gastroentrology of Ankang city central hospital
Ankang
Department of gastroenterology of Anqing municipal hospital
Anqing
Department of infectious disease of Anqing municipal hospital
Anqing
Department of tuberculosis of Baoding infectious disease hospital
Baoding
Department of gastroentrology,the third hospital of PLA
Baoji
Department of infectious disease of Baoji No.2 people's hospital
Baoji
Department of infectious disease,the third hospital of PLA
Baoji
Department of tuberculosis,the third hospital of PLA
Baoji
Department of lymph&breast of Baotou tumor hospital
Baotou
Department of breast disease,Tongzhou matermal&child health hospital of Beijing
Beijing
Department of gastroenterology of Beijing Huairou hospital
Beijing
Department of Hepatology of Beijing Ditan Hospital Capital Medical University
Beijing
Department of hepatology of Peking university people's hospital
Beijing
Department of infection of Peking university first hospital
Beijing
Non infedtious liver disease diagnosis and treatment center,302 military hospital of China
Beijing
Department of gastroenterology,the first affiliated hospital of Bengbu medical college
Bengbu
Department of infectious disease,the first affiliated hospital of Bengbu medical college
Bengbu
Department of infectious disease,the No.123 hospital of PLA
Bengbu
Department of gastroenterology of Cangzhou central hospital
Cangzhou
Department of gastroenterology,the fourth hospital of Jilin university
Changchun
Department of infectious disaese,the fourth hospital of Jilin unversity
Changchun
Department of infectious disease of Changchun infectious disease hospital
Changchun
Department of rhenmatism,the affiliated hospital to Changchun University of Chinese medicine
Changchun
Department of infectious disease,people's hospital Changji hui autonomous prefecture Xinjiang
Changji
2st department of hepatology,the first hospital of Changsha
Changsha
5st internal meidcine of Hunan chest hospital
Changsha
Department of breast disease,the affiliated cancer hospital of Xiangya school
Changsha
Department of infectious disease of Hunan provincial people's hospital
Changsha
Department of infectious disease of Xiangya hospital central south university
Changsha
Department of infectious disease,the second Xiangya hospital of central south university
Changsha
Department of infectious disease,the third Xiangya hospital of central south university
Changsha
Department of tuberculosis of Changsha central hospital
Changsha
Department of infectious disease,Heping hospital affiliated to Changzhi medical university
Changzhi
Department of hepatology of Chengdu tenth people's hospital
Chendu
Department of gastroenterlogy,affiliated hospital of Chenfdu University
Chengdu
Department of gastroenterology,the 416th hospital of CNNC
Chengdu
Department of gastroenterology of Chenzhou No.1 people's hospital
Chenzhou
Department of hepatology of Chenzhou No.2 people's hospital
Chenzhou
Department of infectious disease,the fourth people's hospital of Chenzhou
Chenzhou
Department of infectious disease,the people's hospital of Chizhou
Chizhou
Department of hepatology,Chongqing hospital of TCM
Chongqing
Department of infectious disease of southwest hospital
Chongqing
Department of infectious disease,the second affiliated hospital of Chongqing medical university
Chongqing
Department of gastroenterology of Daqing oilfield general hospital
Daqing
Department of infectious disease of Daqing second hospital
Daqing
Department of hepatology of Datong fourth people's hospital
Datong
Department of gastroenterology,Qilu hospital of Shandong university
Dongying
Department of infectious disease of Shengli oilfield general hospital
Dongying
Department of infectious disease ,Shengli hospital of Shengli oilfield administration
Dongying
Department of infectious disease of Shanxi province Fenyang hospital
Fenyang
Department of infectious disease of Foshan first people's hospital
Foshan
Department of infectious disease of Fujian province Fuqing city hospital
Fuqing
Department of hepatologym,No.2 people's hospital of Fuyang
Fuyang
Department of hepatic-biliary medicine,Fuzhou general hospital of Nanjing military command
Fuzhou
Department of hepatic-biliary medicine,No.476 hospital of PLA
Fuzhou
Department of hepatology of Fuzhou infectious disease hospital
Fuzhou
Department of digestive of Guangdong general hospital
Guangdong
Deaprtment of gastroenterology of Guangzhou first people's hospital
Guangzhou
Department of gastroenterology of Guagdong general hospital
Guangzhou
Department of gsatroenterology of Sun Yat-sen memorial hspital, Sun Yat-sen university
Guangzhou
Department of infectious disease of Guangzhou women&children medical center
Guangzhou
Department of infectious disease,Nanfang hospital of southern medical university
Guangzhou
Department of science education&information of Guangzhou Huiai hospital
Guangzhou
Department of hematology,the affiliated hospital of Guiyang medical university
Guiyang
Department of infectious disease of Guizhou provincial people's hospital
Guiyang
Department of infectious disease,the affiliated hospital of Guiyang medical university
Guiyang
10st department of internal medicine of Heilongjiang province center for tuberculosis control and prevention
Haerbin
1st mepartment of internal medicine Heilongjiang province center for tuberculosis control and prevention
Haerbin
4st department of internal medicine of Heilongjiang province center for tuberculosis control and prevention
Haerbin
5st department of internal medicine of Heilongjiang province center for tuberculosis control and prevention
Haerbin
7st department of internal medicine of Heilongjiang province center for tuberculosis control and prevention
Haerbin
8st department of internal medicine of Heilongjiang province center for tuberculosis control and prevention
Haerbin
9st department of internal medicine of Heilongjiang province center for tuberculosis control and prevention
Haerbin
Department of infectious disease,No.211 hospital of PLA
Haerbin
Department of infectious disease,the first affiliated hosptal of Haerbin medical university
Haerbin
Department of infection of Hainan general hospital
Hainan
Department of infectious disease of Hangzhou Xiaoshan district first people's hospital
Hangzhou
Department of infectious disease of Sir Run Run Shaw hospital,Zhejiang unicersity school of medicine
Hangzhou
1st department of respiration of Hanzhong second people's hospital
Hanzhong
Department of infection of Hanzhou first people's hospital
Hanzhou
Department of gastroenterology,the first affiliated hospital of Anhui medical university
Hefei
Department of infectious disease of Anhui provincial hospital
Hefei
Department of infectious disease of Hefei infectious disease hospital
Hefei
Department of infectious disease,No.105 hospital of PLA
Hefei
Department of infectious disease,the first affiliated hospital of Anhui university of Chinese medicine
Hefei
Department of hematology of First affiliated hospital,Heilongjiang university of Chinese medicine
Heilongjiang
Department of infectious disease,the first affiliated hospital of university of south China
Hengyang
Department of hepatology of Hohhot second hospital
Hohhot
Department of hepatology of Huai'an No.4 people's hospital
Huai'an
department of oncology,Huaiyin hospital of Huai'an city
Huai'an
Department of infectious disease of Yili friendship hospital
Huiyuan
Department of infectious disease,people's hospital of Puluo county
Huizhou
Department of oncology,people's hospital of Puluo county
Huizhou
Department of gastroenterology of inner mongolia forestry general hospital
Inner Mongolia
Department of hepatology of Inner Mongolia international Mongolian medicine hospital
Inner Mongolia
Department of hepatology of No.253 hospital of the PLA
Inner Mongolia
Department of infection, the affiliated hospital of inner mongolia medical hospital
Inner Mongolia
Department of infection,the first affiliated hospital of Baotou medical university
Inner Mongolia
Department of infectious disease of inner mongolia people's hospital
Inner Mongolia
Department of tuberculosis of The Inner Mongolia Autonomous Region fourth hospital
Inner Mongolia
Department of hematology, first affiliated hospital of Jiamusi university
Jiamusi
Internal medicine,the 404 hospital of China national nuclear
Jiayuguan
Department of gastroenterology of Beihua university affiliated hospital
Jilin City
Department of gastroenterology,hepatology hospital of Jilin province
Jilin City
Department of gastroentrology of Jilin integrated TCM&western medicine hospital
Jilin City
Department of hepatology,hepatology hospital of Jilin province
Jilin City
Department of hepatology,the first hospital oof Jilin university
Jilin City
Department of infectious disease of Beihua university affiliated hospital
Jilin City
1st department of hepatology of Jinan hospital for infectious disease
Jinan
Department of endocrinology of Shangdong provincial hospital
Jinan
Department of gastroenterology of Jinan central hospital
Jinan
Department of gastroenterology,Qilu hospital of Shandong university
Jinan
Department of gastroenterology,the second hospital of Shandong university
Jinan
Department of hepatology of Shandong province Qianfoshan hospital
Jinan
Department of hepatology of Shandong provincial hospital of Chinese medicine
Jinan
Department of rheumatology of Shandong provincial hospital
Jinan
Internal medicine of Jinan city Lixia district people's hospital
Jinan
Department of infectious disease of Jincheng anthracite mining group general hospital
Jincheng
Department of infectious disease of Zezhou county people's hospital
Jincheng
2st department of hepatology of Jingmen No.2 people's hospital
Jingmen
Department of gastroenterology of Jingmen No.1 people's hospital
Jingmen
Department of gastroenterology ward 2 of Jingmen No.1 people's hospital
Jingmen
Department of infectious disease of Jingmen No.2 people's hospital
Jingmen
1st internal medicine of Jingzhou hospital for infectious disease
Jingzhou
Department of infectious disease of Jingzhou central hospital
Jingzhou
Department of gastroenterology of Jinzhong City Yuci district people's hospital
Jinzhong
Department of gastroenterology of Qixian county people's hospital
Jinzhong
Department of gastroenterology,the second people's hospital of Jinzhong
Jinzhong
Department of gastroentrology,the first people's hospital of Jinzhong
Jinzhong
Department of infectious disease,the first affiliated hospital of Henan university
Kaifeng
Department of infectious disease of Kashgar prefecture first people's hospital
Kashgar
Department of gastroenterology of Xishan district people's hospital
Kunming
Department of gastroenterology of Yunnan first people's hospital
Kunming
Department of gastroenterology,the first affiliated hospital of Kunming medical university
Kunming
Department of gastroentrology,the first hospital of Kunming
Kunming
Department of infectious disease,Kunming general hospital of Chengdu military
Kunming
Department of infectious disease,the first affiliated hospital of Kunming medical university
Kunming
Department of rheumatology of Yunnan first people's hospital
Kunming
Hepatology center,the second affiliated hospital of Kunming medical university
Kunming
Department of hepatology, Gansu provincial hospital of TCM
Lanzhou
Department of infectious disease of Lanzhou military general hospital
Lanzhou
Department of infestious disease,the first hospital of Lanzhou university
Lanzhou
outpatient of pulmonary hospital of Lanzhou
Lanzhou
Department of infectious disease of Leqing people's hospital
Leqing
Department of hepatology of Liaocheng city infectious disease hospital
Liaocheng
Department of hepatology &respiration of Linfen infectious disease hospital
Linfen
Department of endocrinolnogy of Linyi people's hospital
Linyi
Department of hepatology of Linyi people's hospital
Linyi
Department of tuberculosis of Linyi people's hospital
Linyi
Department of gastroenterology of Lu'an people's hospital
Lu'an
Department of gastroenterology of Luoyang third people's hospital
Luoyang
Department of infectious disease of Luoyang central hospital
Luoyang
Department of infectios disease,the affiliated hospital of southwest hospital
Luzhou
Department of hepatology ward 1 of Mudanjiang Kangan hospital
Mudanjiang
Department of hepatology ward 2 of Mudanjiang Kangan hospital
Mudanjiang
Department of hepatology wardf 10 of Mudanjiang Kangan hospital
Mudanjiang
Department of hepatology wardf 3 of Mudanjiang Kangan hospital
Mudanjiang
Department of hepatology wardf 4 of Mudanjiang Kangan hospital
Mudanjiang
Department of hepatology wardf 9 of Mudanjiang Kangan hospital
Mudanjiang
Department of tuberculosis of ward 11 of Mudanjiang Kangan hospital
Mudanjiang
Department of tuberculosis ward 5 of Mudanjiang Kangan hospital
Mudanjiang
Department of tuberculosis ward 6 of Mudanjiang Kangan hospital
Mudanjiang
Department of tuberculosis ward 7 of Mudanjiang Kangan hospital
Mudanjiang
Department of tuberculosis ward 8 of Mudanjiang Kangan hospital
Mudanjiang
Department of gastroenterology of Jiangxi provincial people's hospital
Nanchang
Department of gastroenterology of the second affiliated hospital to Nanchang university
Nanchang
Department of tuberculosis of Jiangxi provincial chest hospital
Nanchang
Deparment of oncology, Nanjing hospital of TCM
Nanjing
Department of hematology of Nanjing Jiangning hospital
Nanjing
Department of hematology, Jiangsu province hospital of TCM
Nanjing
Department of hepatology,No.81 hospital of PLA
Nanjing
Department of infection of Jiangsu province hospital
Nanjing
Department of infection of Nanjing drum tower hospital
Nanjing
Department of infection,the second hospital of Nanjing
Nanjing
Department of infectious disease of Nanjing Jiangbei people's hospital
Nanjing
Department of infectious,Jiangsu procince hospital of TCM
Nanjing
Department of oncology , Jiangning hospital of Nanjing city
Nanjing
Department on tuberculosis of Nanjing chest hospital
Nanjing
Department of gastroenterology,the first affiliated hospital of Guangxi medical university
Nanning
Department of hepatology,the first affiliated hospital of Guangxi university of Chinese medicine
Nanning
Department of oncology,the first affiliated hospital of Guangxi university of Chinese medicine
Nanning
Department of gastroenterology of Ningbo medical treatment center Lihuili hospital
Ningbo
Department of gastroenterology,Yinzhou hospital affiliated to medical school of Ningbo university
Ningbo
Department of hematology of Ningbo medical treatment center Lihuili hospital
Ningbo
Department of hepatology of Ningbo No.2 hospital
Ningbo
Department of hepatology,No.113 hospital of PLA
Ningbo
Department of psychiatry of Ningbo Kangning hospital
Ningbo
Department of infectious disaese of Erdos second people's hospital
Ordos
Department of oncology of Jungar Banner central hospital
Ordos
Department of tuberculosis of Pingdingshan third people's hospital
Pingdingshan
Department of gastroenterology of Jiangxi Pingxiang people's hospital
Pingxiang
Department of gastroenterology,Pingxiang city hospital of Chinese medicine
Pingxiang
Department of infedtious disease of Pingyang county hospital of Chinese medicine
Pingyang
Department of infectious disease,Puyang oilfield general hospital
Pujiang
Department of tuberculosis,the fifth people hospital of Puyang
Pujiang
Department of digestive,the affiliated hospital of Qingdao university
Qingdao
Department of endocrinology,the affiliated hospital of Qingdao university
Qingdao
Department of gastroenterology of Qingdao municipal hospital
Qingdao
Department of hepatology,the affiliated hospital of Qingdao university
Qingdao
Department of digestive of Qinghai provincial people's hospital
Qinghai
Department of hepatology,Qinghai province hospital for infectious disease
Qinghai
Deqpartment of gastroenterology of Qinghai university affiliated hospital
Qinghai
Department of gastroenterology,the third hosital of Qinhuangdao
Qinhuangdao
Department of hepatology,the third hospital of Qinhuangdao
Qinhuangdao
Department of infectious disease of Qiqihar infectious disease hospital
Qiqihar
Department og gastroenterology,the first hospital of Qiqihar city
Qiqihar
Department of infectious disease of Ruian people's hospital
Ruian
Department of gastroenterology of Sanmenxia central hospital
Sanmenxia
Department of hematology of Sanmenxia central hospital
Sanmenxia
Department of infectious disease of Sanmenxia central hospital
Sanmenxia
Department of gastroenterology,No.301 hospital Sanya branch
Sanya
Clinical research center for tuberculosis of Shanghai pulmonary hospital
Shanghai
Department of Digestive Diseases of Shanghai Tongji Hospital
Shanghai
Department of Digestive Diseases of The Renji Hospital
Shanghai
Department of digestive of Shanghai Tongji hospital
Shanghai
Department of gastroenterolgy of Huadong hispital affiliated to Fudan university
Shanghai
Department of gastroenterology,the affiliated Zhongshan hospital of Fudan university
Shanghai
Department of hepatocirrhosis of Shuguang hospital affiliated Shanghai University of T.C.M
Shanghai
Department of hepatology of No.85 hospital of PLA
Shanghai
Department of infection of No.85 hospital of PLA
Shanghai
Department of Infection of Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Department of infectious disease of Longhua hospital affiliated to Shianghai univesity of Chinese medicine
Shanghai
Department of infectious disease of Shanghai Songjiang district people's hospital
Shanghai
Department of infectious disease of Tongren hospital
Shanghai
Department of infectious disease,Huashan hospital affiliated to Fudan university
Shanghai
Department of oncology of Shanghai Putuo district central hospital
Shanghai
Department of oncology of the sixth people's hospital affiliated to Shanghai Jiaotong university
Shanghai
Department of pediatrics of Shanghai first people's hospital Songjiang branch
Shanghai
Department of digestive of the second affiliated hospital of Xi'an jiaotong university
Shangxi
Department of infection of the second affiliated hospital of Xi'an jiaotong university
Shangxi
Department of gastroenterology of Shanluo central hospital
Shanluo
Department of infectious disease of Shanluo central hospital
Shanluo
Department of infectious disease of Shaoxing central hospital
Shaoxing
Department of infectious disease of Shaoyang central hospital
Shaoyang
Department of infectious disease,Shengjing hospital of China medical university
Shenyang
Department of hepatology of Shenzhen third people's hospital
Shenzhen
Department of infectious disease of Shenzhen third people's hospital
Shenzhen
Department of pulmonary dedicine of Shenzhen third people's hospital
Shenzhen
Department of gastroenterology of Hebei general hospital
Shijiazhuang
Department of gastroenterology,the first hospital of Hebei medical university
Shijiazhuang
Department of hematology,the first hospital of Hebei medical university
Shijiazhuang
Department of hepatology,the first hospital of Hebei medical university
Shijiazhuang
Department of hepatology,the third hodpital of Hebei medical university
Shijiazhuang
Department of tuberculosis of Hubei province chest hospital
Shijiazhuang
2st department of gastroenterology of Shiyan people's hospital
Shiyan
Department of infectious disease of Dongfeng company general hospital
Shiyan
Department of infectious disease of Taihe hospital
Shiyan
Department of tuberculosis of Xiyuan hospital of Shiyan city
Shiyan
Department of infestious disease,the first people's hospital of Shunde
Shunde
Department of gastroenterology of Songyuan central hospital
Songyuan
Department of hepatology of Jilin oilfiled general hospital
Songyuan
Department of infectious disease of Suzhou municipal hospital
Suzhou
Department of infectious disease,the fifth people's hospital of Suzhou
Suzhou
Department of i fectious disease of Taian city central hospital
Taian
Department of tuberculosis of Taian cancer hospital
Taian
Department of gastroenterology,the second hospital of Shanxi medical university
Taiyuan, Shanxi
1st department of tuberculosis of Taiyuan fourth people's hospital
Taiyuan
Department of hepatology,Shanxi provincial hospital of Chinese medicine
Taiyuan
Department of tuberculosis of Taiyuan fourth people's hospital
Taiyuan
Department of hematology&oncology,Taizhou hospital of Zhejiang province
Taizhou
Department of infectious disease of Tianchang people's hospital
Tianchang
Department of hepatology of Tianjin first hospital
Tianjin
Department of hepatology of Tianjin third central hospital
Tianjin
Department of hepatology,first teaching hospital of Tianjin university
Tianjin
Department of hepatology,The affiliated hospital of logistics university of people's armed police force
Tianjin
Department of oncology of Tianjin medical university general hospital
Tianjin
Department of rheumatology of Tianjin first center hospital
Tianjin
Department of infestious disaese of Tibet autonomous prefecture people's hospital
Tibet
1st department of oncology of Tonghua central hospital
Tonghua
3st department of oncology of Tonghua central hospital
Tonghua
Department of oncology of Tonghua second people's hospital
Tonghua
Department of oncology&hematology of Tonghua people's hospital
Tonghua
Department of infectious disease of Tongliao infectious disease hospital
Tongliao
Department of hepatology of The Xinjiang production and construction Corps hospital
Ürümqi
Department of infectious disease of URUMQI friendship hospital
Ürümqi
2st department of tuberculosis of Weifang No.2 people's hospital
Weifang
Department of gastroenterology of Weifang people's hospital
Weifang
Department of gastroenterology of Weihai central hospital
Weihai
Department of gastroenterology of Weihai municipal hospital
Weihai
Department of infectious disease of Weinan central hospital
Weinan
Department of infectious disease,the first people's hospital of Wenling
Wenling
Department of hematology of the first affiliated hospital of Wenzhou medical university
Wenzhou
Department of infectious disease of Wencheng county people's hospital
Wenzhou
Department of infectious disease,Wenshou hospital of Chinesemedicine
Wenzhou
Department of oncology of Wuhai people's hospital
Wuhai
1st internal medicine of Wuhan institute for tuberculosis control
Wuhan
3st internal medicine of Wuhan institute for tuberculosis control
Wuhan
4st internal medicine of Wuhan institute for tuberculosis control
Wuhan
5st internal medicine of Wuhan institute for tuberculosis control
Wuhan
Departmeent of gastroenterology of fifth hodpital in Wuhan
Wuhan
Department of gastroenterology of Wuhan integrated TCM&western medicine hospital
Wuhan
Department of gastroenterology of Wuhan union hospiital
Wuhan
Department of gastroenterology,the central hospital of Wuhan
Wuhan
Department of gastroenterology,Wuhan general hospital of Guangzhou military
Wuhan
Department of hepatology of Wuhan seventh hospital
Wuhan
Department of hepatology,Hubei provincial hospital of TCM
Wuhan
Department of hepatology,Wuhan general hospital of Guangzhou military
Wuhan
Department of infectious disease of Puren hospital
Wuhan
Department of infectious disease of Wuhan iron and steel(group) corp. staff hospital
Wuhan
Department of infectious disease of Wuhan iron and steel(group) Crop. second staff hospital
Wuhan
About this study
Official title: A Retrospective Epidemiologic Study on Incidence and Treatment Status of Hospitalized Drug Induced Liver Injury Patients in Mainland China
This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.
Read the detailed description
This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.
It investigates medical records of patients who were hospitalized during 2012 to 2014. Those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
- Conditions
- Drug-Induced Liver Injury
- Keywords
- Drug-Induced Liver Injury, DILI
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of drug-induced liver injury
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-Induced Liver InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drug Induced Liver Disease Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Unimed Scientific Inc.
- Responsible party
- Sponsor
- Investigators
- Yimin Mao, MD, Study chair, RenJi HospitalChengwei Chen, MD, Study chair, No. 85 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407964
- Sponsor's protocol ID
- 2012ZX09303-001
- Acronym
- DILI-R
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li J, Zhang J, Xu X, Fang W, Qu S, Jin F, Zhou J, Han X, Raza HK, Li X, Mao Y. Hugan tablets for the treatment of RUCAM based drug-induced liver injury: a propensity score matching analysis using a nationwide database. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1543-1550. doi: 10.1080/17512433.2021.1981859. Epub 2021 Sep 22.
PubMed 34521298
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Epidemiologic Study on Incidence and Treatment Status of Hospitalized Drug Induced Liver Injury Patients in Mainland China
- ClinicalTrials.gov ID
- NCT02407964
- Acronym / sponsor ID
- DILI-R / 2012ZX09303-001
- Conditions
- Drug-Induced Liver Injury
- Keywords
- Drug-Induced Liver Injury, DILI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Drug Induced Liver Disease Study GroupUniversity, hospital or other
- Collaborators
- Unimed Scientific Inc.
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.
Detailed description
This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.
It investigates medical records of patients who were hospitalized during 2012 to 2014. Those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were hospitalized during 2012 to 2014.
Key inclusion criteria (2 listed)
- Any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
- The drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature.
Key exclusion criteria (3 listed)
- Confirmed non-drug induced liver injury.
- Insufficient clinical data supporting the diagnosis of drug-induced liver injury.
- Liver injury resulted from poisons and chemicals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnosis of drug-induced liver injury
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 34521298Li J, Zhang J, Xu X, Fang W, Qu S, Jin F, Zhou J, Han X, Raza HK, Li X, Mao Y. Hugan tablets for the treatment of RUCAM based drug-induced liver injury: a propensity score matching analysis using a nationwide database. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1543-1550. doi: 10.1080/17512433.2021.1981859. Epub 2021 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yimin Mao, MD study chair
RenJi Hospital
Chengwei Chen, MD study chair
No. 85 Hospital of PLA
371 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-Induced Liver Injury, run by Drug Induced Liver Disease Study Group at 371 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 371 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of drug-induced liver injury (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.