Prognostic model for drug-induced liver injury in China

A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study

This study is trying to understand the causes and outcomes of drug-induced liver injury in China to help create a better tool for predicting how patients will do.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Locations: 13 sites (Beijing, Beijing Municipality and 12 other locations)
• Trial ID: NCT05060289 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a nationwide cohort to investigate the clinical characteristics, causative drugs or herbs, outcomes, and risk factors associated with drug-induced liver injury (DILI) in China. It will involve a multi-center approach to collect long-term prognostic data and develop a prognostic model incorporating novel serum biomarkers for DILI. The study will also validate these models to improve patient prognosis.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with drug-induced liver injury based on specific biochemical criteria and expert evaluation.

Not a fit: Patients with liver injury due to viral infections, autoimmune diseases, or other specified exclusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prognostic tools for patients suffering from drug-induced liver injury.

How similar studies have performed: Other studies have explored prognostic models for liver injury, but this specific approach focusing on a nationwide cohort in China is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality and 12 other locations

• Beijing 302 Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Friendship Hospital, Capital Medical University — Beijing, China (Recruiting)
• Beijing You 'an Hospital, Capital Medical University — Beijing, China (Recruiting)
• Beijing Ditan Hospital — Beijing, China (Active_not_recruiting)
• Peking University Third Hospital — Beijing, China (Active_not_recruiting)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, China (Recruiting)
• Qinzhou First People's Hospital — Guangxi, China (Active_not_recruiting)
• Hebei CNPC Central Hospital — Hebei, China (Active_not_recruiting)
• Jiaozuo People's Hospital — Jiaozuo, China (Recruiting)
• The Second Hospital of Lanzhou University — Lanzhou, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
• Qinghai People's Hospital — Qinghai, China (Recruiting)
• Yuncheng Central Hospital — Yuncheng, China (Recruiting)

Study contacts

• Principal investigator: Zhengsheng Zou — Beijing 302 Hospital
• Study coordinator: Yan Wang

Conditions Drug-induced Liver Injury; prognostic model; biomarker; endpoint event