Observational study on drug-induced liver injury in China
Official title: A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
Run by Drug Induced Liver Disease Study Group · NCT02961413 · Data updated 2026-11-12
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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Drug Induced Liver Disease Study Group Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | April 2016 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | May 4, 2025 |
| Trial ID | NCT02961413 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with drug-induced liver injury of varying types and severity who can provide informed consent.
✕Probably not a fit
Patients with liver injury not caused by drugs will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center, prospective cohort study aims to assess the clinical characteristics, disease progression, and influencing factors of patients with drug-induced liver injury (DILI) in various hospitals across China. The study will gather data on suspected drug causes of DILI, liver biochemical abnormalities, and the compliance of clinical practices with established guidelines. It will also evaluate histological features and specific population characteristics, such as the elderly and children with underlying liver conditions. The research is conducted in both Western and traditional Chinese medicine hospitals, providing a comprehensive view of DILI in the region.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of DILI, leading to improved diagnosis and management strategies for affected patients.
How similar studies have gone: While this study focuses on a specific regional context, similar observational studies have shown success in understanding drug-induced liver injury in other populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines * RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury * patient can provide informed consent form Exclusion Criteria: * non-drug-induced liver injury
Where it's running
-
Renji hospital
Shanghai, China Recruiting
Study contacts
- Principal investigator: Xingfang Li — Pulmonary Hospital of Lanzhou
- Study coordinator: Chunxia Zhang
- Email: chunxia.zhang@unimedsci.com
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Treating acute drug-induced liver injury with high bilirubin using steroids
This trial will test whether adding glucocorticoid (steroid) treatment to standard care helps adults with acute drug‑induced liver injury and high bilirubin recover faster and avoid worsening liver problems.
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Comparing two diagnostic methods for drug-induced liver injury
This study is testing two different scoring systems to see which one better helps doctors diagnose drug-induced liver injury in hospitalized patients.
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Understanding itching caused by drug-induced liver injury
This study looks at how common itching is for people with drug-induced liver injury to better understand it and help find new treatments.
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Prognostic model for drug-induced liver injury in China
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.