Clinical trial Recruiting at 1 site Observational

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.

More Drug Induced Liver Injury trials

Quick facts

Study typeObservational
SexAll
Enrollment10000 (estimated)
SponsorDrug Induced Liver Disease Study Group
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedApril 2016
Main results expectedDecember 2030
Study endsDecember 2030
Registry record updatedMay 4, 2025
Trial IDNCT02961413 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.

  • 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.

    Recruiting General Hospital of Shenyang Military Region · Shenyang, Liaoning · NCT06922669

  • 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.

    Recruiting Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT06771011

  • 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.

    Recruiting University of Nottingham · Nottingham · NCT06446609

  • 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.

    Recruiting at 9 sites Beijing Friendship Hospital · Beijing, Beijing Municipality and 12 other locations · NCT05060289

  • 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

  • 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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.