Prognostic model for drug-induced liver injury in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• The Second Affiliated Hospital of Dalian Medical University
  Dalian, China Recruiting
• Jiaozuo People's Hospital
  Jiaozuo, China Recruiting
• The Second Hospital of Lanzhou University
  Lanzhou, China Recruiting

Study contacts

• Principal investigator: Zhengsheng Zou — Beijing 302 Hospital
• Study coordinator: Yan Wang
• Email: wangyanpku@163.com
• Phone: 18810530724

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two diagnostic methods for drug-induced liver injury

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• Understanding itching caused by drug-induced liver injury

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  Recruiting University of Nottingham · Nottingham · NCT06446609

• Identifying genetic factors for acetaminophen-induced liver injury in Chinese patients

  This study is trying to find out if certain genes make Chinese patients more likely to have liver problems from taking acetaminophen.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT04964310

• Observational study on drug-induced liver injury in China

  This study looks at how drug-induced liver injury affects patients in China to better understand its causes and how it progresses, especially in different age groups and health conditions.

  Recruiting Drug Induced Liver Disease Study Group · Shanghai · NCT02961413

• Registry for patients with drug-induced liver injury

  This study is creating a national registry to collect information and samples from people who have had liver injuries caused by medications, so researchers can learn more about how these injuries happen.

  Recruiting at 6 sites Duke University · Los Angeles, California and 5 other locations · NCT00360646

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.