Clinical trial NCT05060289: A Prognostic Model for Drug-induced Liver Injury in China
Official title: A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug-induced Liver Injury
Keywords: prognostic model(s)
biomarker(s)
endpoint event(s)
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult with drug-induced liver injury

Brief summary: A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.

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 .

Detailed description: Research Objectives:

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.

Eligibility criteria: Inclusion Criteria:

1. RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
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:

1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
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.

Primary outcomes:
measure: death/liver transplantation
timeFrame: 1 year
measure: acute liver failure
timeFrame: 1 year
Secondary outcomes:
measure: chronic DILI
timeFrame: 2 years
measure: recovery
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing You 'an Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Ditan Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
city: Guangxi
country: China
facility: Qinzhou First People's Hospital
city: Hebei
country: China
facility: Hebei CNPC Central Hospital
city: Jiaozuo
country: China
facility: Jiaozuo People's Hospital
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Qinghai
country: China
facility: Qinghai People's Hospital
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
Study officials:
affiliation: Beijing Friendship Hospital
name: Xinyan Zhao
role: STUDY_CHAIR
affiliation: Beijing 302 Hospital
name: Zhengsheng Zou
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing You 'an Hospital, Capital Medical University
name: Yu Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Qinghai People's Hospital
name: Juan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Qinghai People's Hospital
name: Pingying Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Qinzhou First People's Hospital
name: Xiaoju Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Lanzhou University Second Hospital
name: Liang Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei CNPC Central Hospital
name: Juan Luo
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiaozuo People's Hospital
name: Huahua Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiaozuo People's Hospital
name: Hui Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiaozuo People's Hospital
name: Jikang Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Municipal Hospital
name: Doudou Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Qiuju Tian
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Dalian Medical University
name: Rongkuan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Lu Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuncheng Central Hospital
name: Liuyi Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Lu Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Yuanjiao Gao
role: PRINCIPAL_INVESTIGATOR
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