A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Drug-induced Liver Injury. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
Overview
This is a multi-center, prospective, non-interventional cohort study . Its primary objectives are: 1. assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice; 2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
Detailed description
The main purpose of this study is to understand patients with DILI clinical outcome and influencing factors in China's second and tertiary general hospitals (including Western medicine hospital, Chinese medicine hospital andIntegrated traditional Chinese and Western Medicine Hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, Pulmonary, etc.) in mainland.
The main purpose
1. assess the DILI patients' clinical outcomes and influencing factors in the real world; 2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
Secondary objectives
1. assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.; 2. evaluate the histological features of DILI patients; 3. assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)
Primary outcome measures
- Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji hospital — Shanghai
Identifiers
NCT: NCT02961413 · 2012ZX09303-002