A Prognostic Model for Drug-induced Liver Injury in China
NCT ID: NCT05060289
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2022-05-25
2028-12-31
Brief Summary
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A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .
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Detailed Description
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1. To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data.
2. To establish and verify prognostic model(s) of DILI in China.
3. To explore novel serum biomarkers for the prognosis of DILI.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Modeling group
The data of modeling group is used to construct a predictive model of DILI endpoint events.
No interventions assigned to this group
Validation group
Validation group is used to validate the predictive model externally.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
3. Onset to enrollment ≤3 months.
Exclusion Criteria
2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
3. Hypoxic ischemic hepatitis and congestive liver disease.
4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.
5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
7. Parasitic infection.
8. Sepsis.
9. Previous liver transplantation or bone marrow transplantation.
10. Pregnancy or lactation.
11. Genetic and metabolic liver diseases.
18 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Zhao Xinyan
Professor
Principal Investigators
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Xinyan Zhao
Role: STUDY_CHAIR
Beijing Friendship Hospital
Zhengsheng Zou
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital
Yu Chen
Role: PRINCIPAL_INVESTIGATOR
Beijing You 'an Hospital, Capital Medical University
Juan Li
Role: PRINCIPAL_INVESTIGATOR
Qinghai People's Hospital
Pingying Li
Role: PRINCIPAL_INVESTIGATOR
Qinghai People's Hospital
Xiaoju Liu
Role: PRINCIPAL_INVESTIGATOR
Qinzhou First People's Hospital
Liang Wang
Role: PRINCIPAL_INVESTIGATOR
Lanzhou University Second Hospital
Juan Luo
Role: PRINCIPAL_INVESTIGATOR
Hebei CNPC Central Hospital
Huahua Wang
Role: PRINCIPAL_INVESTIGATOR
Jiaozuo People's Hospital
Hui Wang
Role: PRINCIPAL_INVESTIGATOR
Jiaozuo People's Hospital
Jikang Yang
Role: PRINCIPAL_INVESTIGATOR
Jiaozuo People's Hospital
Doudou Hu
Role: PRINCIPAL_INVESTIGATOR
Qingdao Municipal Hospital
Qiuju Tian
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Rongkuan Li
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Dalian Medical University
Lu Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Liuyi Chang
Role: PRINCIPAL_INVESTIGATOR
Yuncheng Central Hospital
Lu Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Yuanjiao Gao
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Locations
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Beijing 302 Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing You 'an Hospital, Capital Medical University
Beijing, , China
Beijing Ditan Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The Second Affiliated Hospital of Dalian Medical University
Dalian, , China
Qinzhou First People's Hospital
Guangxi, , China
Hebei CNPC Central Hospital
Hebei, , China
Jiaozuo People's Hospital
Jiaozuo, , China
The Second Hospital of Lanzhou University
Lanzhou, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Qinghai People's Hospital
Qinghai, , China
Yuncheng Central Hospital
Yuncheng, , China
Countries
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Central Contacts
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Facility Contacts
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Zhengsheng Zou
Role: primary
Yu Chen
Role: primary
Fangcheng Zhao
Role: primary
Huahua Wang
Role: primary
Liang Wang
Role: primary
Qiuju Tian
Role: primary
Juan Li
Role: primary
Liuyi Chang
Role: primary
Other Identifiers
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2021-P2-290-01
Identifier Type: -
Identifier Source: org_study_id
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