A Prognostic Model for Drug-induced Liver Injury in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Drug-induced Liver Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study
Overview
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.
Primary outcome measures
- death/liver transplantation [Time frame: 1 year]
- acute liver failure [Time frame: 1 year]
Secondary outcome measures (2)
- chronic DILI [Time frame: 2 years]
- recovery [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
- Onset to enrollment ≤3 months.
Exclusion criteria
- Hepatotropic viral infection: hepatitis A, B, C, D and E.
- Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- Hypoxic ischemic hepatitis and congestive liver disease.
- Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
- Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
- Parasitic infection.
- Sepsis.
- Previous liver transplantation or bone marrow transplantation.
- Pregnancy or lactation.
- Genetic and metabolic liver diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 13 centers
- Beijing 302 Hospital — Beijing
- Beijing Friendship Hospital, Capital Medical University — Beijing
- Beijing You 'an Hospital, Capital Medical University — Beijing
- Beijing Ditan Hospital — Beijing
- Peking University Third Hospital — Beijing
- The Second Affiliated Hospital of Dalian Medical University — Dalian
- Qinzhou First People's Hospital — Guangxi
- Hebei CNPC Central Hospital — Hebei
- … and 5 more centers
Identifiers
NCT: NCT05060289 · 2021-P2-290-01