Drug-induced Liver InjuryDILI-PMNCT05060289
A Prognostic Model for Drug-induced Liver Injury in China
An observational study of Drug-induced Liver Injury, run by Beijing Friendship Hospital at 13 sites in China.
Trial summary
A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-induced Liver Injury
- How many people
- 3,000 participants
- Where
- 13 sitesChina
- Study dates
- 25 May 2022to 31 Dec 2028
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult with drug-induced liver injury
Who may be able to join
- RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
- RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
- Onset to enrollment ≤3 months.
Who cannot join
- Hepatotropic viral infection: hepatitis A, B, C, D and E.
- Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- Hypoxic ischemic hepatitis and congestive liver disease.
- Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
- Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
Show all 11Show fewer
- Parasitic infection.
- Sepsis.
- Previous liver transplantation or bone marrow transplantation.
- Pregnancy or lactation.
- Genetic and metabolic liver diseases.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 9 recruiting
- Recruiting
Beijing 302 Hospital
Beijing, Beijing Municipality, 100166
Zhengsheng Zou
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Zikun Ma, mazikun0114@163.com
Xinyan Zhao
- Recruiting
Beijing You 'an Hospital, Capital Medical University
Beijing, 100069
Yu Chen
Liwei Liu
- Active, not recruiting
Beijing Ditan Hospital
Beijing, 100102
- Active, not recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, 116023
Fangcheng Zhao
Rongkuan Li
- Active, not recruiting
Qinzhou First People's Hospital
Guangxi, 535009
- Active, not recruiting
Hebei CNPC Central Hospital
Hebei, 050011
- Recruiting
Jiaozuo People's Hospital
Jiaozuo, 454002
Huahua Wang
Jikang Yang
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, 730046
Liang Wang
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, 266003
Qiuju Tian
- Recruiting
Qinghai People's Hospital
Qinghai, 810007
Juan Li
Pingying Li
- Recruiting
Yuncheng Central Hospital
Yuncheng, 044099
Liuyi Chang
Liuyi Chang
About this study
Official title: A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study
A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.
A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .
Read the detailed description
Research Objectives:
- To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data.
- To establish and verify prognostic model(s) of DILI in China.
- To explore novel serum biomarkers for the prognosis of DILI.
- Conditions
- Drug-induced Liver Injury
- Keywords
- prognostic model(s), biomarker(s), endpoint event(s)
- 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 |
|---|---|---|
| Modeling group | The data of modeling group is used to construct a predictive model of DILI endpoint events. | |
| Validation group | Validation group is used to validate the predictive model externally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
death/liver transplantation
DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) .
DILI is the primary indication for liver transplantation.
Measured: 1 year
acute liver failure
Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.
Measured: 1 year
Secondary outcomes (2)
chronic DILI
Chronicity is defined as the presence of any one of the following: (i) persistently elevated liver biochemistry indexes; (ii) radiological or histological evidence of persistent liver injury at one year after DILI onset.
Measured: 2 years
recovery
Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and total bilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start25 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- 3,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Xinyan, Beijing Friendship Hospital
- Investigators
- Xinyan Zhao, Study chair, Beijing Friendship HospitalZhengsheng Zou, Principal investigator, Beijing 302 HospitalYu Chen, Principal investigator, Beijing You 'an Hospital, Capital Medical UniversityJuan Li, Principal investigator, Qinghai People's HospitalPingying Li, Principal investigator, Qinghai People's HospitalXiaoju Liu, Principal investigator, Qinzhou First People's HospitalLiang Wang, Principal investigator, Lanzhou University Second HospitalJuan Luo, Principal investigator, Hebei CNPC Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060289
- Sponsor's protocol ID
- 2021-P2-290-01
- Acronym
- DILI-PM
- Status last verified
- Jan 2025
- First submitted
- 14 Sep 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05060289
- Acronym / sponsor ID
- DILI-PM / 2021-P2-290-01
- Conditions
- Drug-induced Liver Injury
- Keywords
- prognostic model(s), biomarker(s), endpoint event(s)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Sep 2021 (actual)
- 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.
A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.
A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .
Detailed description
Research Objectives:
- To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data.
- To establish and verify prognostic model(s) of DILI in China.
- To explore novel serum biomarkers for the prognosis of DILI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling group | – | –The data of modeling group is used to construct a predictive model of DILI endpoint events. |
| Validation group | – | –Validation group is used to validate the predictive model externally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult with drug-induced liver injury
Key inclusion criteria (3 listed)
- RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
- RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
- Onset to enrollment ≤3 months.
Key exclusion criteria (11 listed)
- Hepatotropic viral infection: hepatitis A, B, C, D and E.
- Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- Hypoxic ischemic hepatitis and congestive liver disease.
- Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
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
death/liver transplantation
Time frame: 1 year
DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) . DILI is the primary indication for liver transplantation.
acute liver failure
Time frame: 1 year
Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.
2 secondary outcomes
chronic DILI
Time frame: 2 years
recovery
Time frame: 2 years
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Xinyan Zhao study chair
Beijing Friendship Hospital
Zhengsheng Zou principal investigator
Beijing 302 Hospital
Yu Chen principal investigator
Beijing You 'an Hospital, Capital Medical University
13 sites 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 Beijing Friendship Hospital at 13 sites 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 11 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 Yan Wang (18810530724, wangyanpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death/liver transplantation (time frame: 1 year). The study lists 2 primary outcomes in all. 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 22 Sep 2025.