Drug-induced Liver InjuryDILI-PNCT02961413
A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）
An observational study of Drug-induced Liver Injury, run by Drug Induced Liver Disease Study Group at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-induced Liver Injury
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with drug-induced liver injury
Who may be able to join
- 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
Who cannot join
- non-drug-induced liver injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chunxia Zhang contact
About this study
Official title: A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
This is a multi-center, prospective, non-interventional cohort study .
Its primary objectives are:
- assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;
- learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
Read the 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
- assess the DILI patients' clinical outcomes and influencing factors in the real world;
- learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
Secondary objectives
- assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.;
- evaluate the histological features of DILI patients;
- assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)
- Conditions
- Drug-induced Liver Injury
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Compound glycyrrhizin tablets / injection | |
| cohort 2 | Isoglycyrrhizinate magnesium injection / diammonium glycyrrhizinate enteric-coated capsules | |
| cohort 3 | Bicyclol | |
| cohort 4 | Silibinin capsules | |
| cohort 5 | Ursodeoxycholic acid capsules | |
| cohort 6 | N- acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-induced Liver InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drug Induced Liver Disease Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yimin Mao, Study chair, RenJi HospitalChengwei Chen, Study chair, No.85 Hospital of PLAXingfang Li, Principal investigator, Pulmonary Hospital of LanzhouYiling Li, Principal investigator, First Hospital of China Medical UniversityDongliang Li, Principal investigator, Fuzhou General HospitalSuocai Zhang, Principal investigator, Changzhou Third People 's HospitalRongxia Sang, Principal investigator, First Hospital of Shijiazhuang CityZhihui Li, Principal investigator, Hebei Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961413
- Sponsor's protocol ID
- 2012ZX09303-002
- Acronym
- DILI-P
- Status last verified
- Apr 2025
- First submitted
- 24 Oct 2016
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
- ClinicalTrials.gov ID
- NCT02961413
- Acronym / sponsor ID
- DILI-P / 2012ZX09303-002
- Conditions
- Drug-induced Liver Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Drug Induced Liver Disease Study GroupUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, non-interventional cohort study .
Its primary objectives are:
- assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;
- 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
- assess the DILI patients' clinical outcomes and influencing factors in the real world;
- learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
Secondary objectives
- assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.;
- evaluate the histological features of DILI patients;
- assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | – | –Compound glycyrrhizin tablets / injection |
| cohort 2 | – | –Isoglycyrrhizinate magnesium injection / diammonium glycyrrhizinate enteric-coated capsules |
| cohort 3 | – | –Bicyclol |
| cohort 4 | – | –Silibinin capsules |
| cohort 5 | – | –Ursodeoxycholic acid capsules |
| cohort 6 | – | –N- acetylcysteine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with drug-induced liver injury
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- non-drug-induced liver injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
Related trials for Drug-induced Liver Injury
Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
Drug-Induced Acute Liver Injury, Tuberculosis (TB)
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 3
Misocholic Tablets for Non-Viral Elevated Liver Enzymes
Alcohol-Related Liver Disease, Drug-Induced Liver Injury
Not yet recruitingObservational study
Prevalence and Prognosis of Drug-Induced Liver Injury
Drug-Induced Liver Injury
RecruitingObservational study
Drug-induced Liver Injury: Itching Study
Drug Induced Liver Injury, Pruritus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunxia Zhang contact
Yimin Mao study chair
RenJi Hospital
Chengwei Chen study chair
No.85 Hospital of PLA
Xingfang Li principal investigator
Pulmonary Hospital of Lanzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-induced Liver Injury, run by Drug Induced Liver Disease Study Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunxia Zhang (chunxia.zhang@unimedsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.