Observational study on drug-induced liver injury in China
A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland 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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | Drug Induced Liver Disease Study Group Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT02961413 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with drug-induced liver injury of varying types and severity who can provide informed consent.
Not a fit: Patients with liver injury not caused by drugs will not benefit from this study.
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 performed: While this study focuses on a specific regional context, similar observational studies have shown success in understanding drug-induced liver injury in other populations.
Eligibility criteria
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 this trial is running
Shanghai
- Renji hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xingfang Li — Pulmonary Hospital of Lanzhou
- Study coordinator: Chunxia Zhang
- Email: chunxia.zhang@unimedsci.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.