Actively Recruiting
A Prognostic Model for Drug-induced Liver Injury in China: A Multi-center, Prospective Cohort Study
Led by Beijing Friendship Hospital · Updated on 2025-09-22
3000
Participants Needed
13
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-center observational study in China to better understand drug-induced liver injury (DILI). The study aims to explore the clinical features, identify the drugs or herbs causing DILI, assess patient outcomes, and discover new serum markers. The goal is to develop and validate a prognostic model incorporating these novel markers to improve prediction of patient prognosis in China. Participants will be grouped into a modeling group to help build a predictive model for DILI outcomes, and a validation group to test the accuracy of this model. The study collects long-term data to establish and verify these prognostic tools. No experimental treatments are given as this is an observational cohort study. During the study, researchers will monitor participants for key outcomes such as death, liver transplantation, and acute liver failure over one year, as well as chronic DILI and recovery over two years. Data will be collected through regular clinical assessments and laboratory tests. This long-term follow-up will help improve understanding of DILI prognosis and validate new serum biomarkers. Participants will be involved over extended periods to ensure comprehensive outcome measurement.
CONDITIONS
Brief Title
A Prognostic Model for Drug-induced Liver Injury in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- RUCAM score of 6 or higher with one of the following: ALT ≥ 5 times normal limit, or ALP ≥ 2 times normal limit, or ALT ≥ 3 times normal limit and total bilirubin ≥ 2 times normal limit
- For RUCAM scores between 3 and 5, diagnosis agreed upon by at least 4 of 5 experienced hepatologists
- Onset of DILI symptoms within 3 months before enrollment
You will not qualify if you...
- Hepatitis A, B, C, D, or E viral infections
- Non-hepatotropic viral infections such as cytomegalovirus or Epstein-Barr virus
- Hypoxic ischemic hepatitis or congestive liver disease
- Excessive alcohol consumption (men > 40g/day, women > 20g/day) for 5 years or more
- Biliary obstruction, primary biliary cholangitis, or primary sclerosing cholangitis
- Autoimmune hepatitis with high simplified or complicated score or uncertain diagnosis
- Parasitic infections
- Sepsis
- Previous liver or bone marrow transplantation
- Pregnancy or lactation
- Genetic and metabolic liver diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed over time to collect data on liver injury progression, recovery, and outcomes.
Regular visits depending on clinical status
Trial Site Locations
Total: 13 locations
1
Beijing 302 Hospital
Beijing, Beijing Municipality, China, 100166
Actively Recruiting
2
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Actively Recruiting
3
Beijing You 'an Hospital, Capital Medical University
Beijing, China, 100069
Actively Recruiting
4
Beijing Ditan Hospital
Beijing, China, 100102
Active, Not Recruiting
5
Peking University Third Hospital
Beijing, China, 100191
Active, Not Recruiting
6
The Second Affiliated Hospital of Dalian Medical University
Dalian, China, 116023
Actively Recruiting
7
Qinzhou First People's Hospital
Guangxi, China, 535009
Active, Not Recruiting
8
Hebei CNPC Central Hospital
Hebei, China, 050011
Active, Not Recruiting
9
Jiaozuo People's Hospital
Jiaozuo, China, 454002
Actively Recruiting
10
The Second Hospital of Lanzhou University
Lanzhou, China, 730046
Actively Recruiting
11
The Affiliated Hospital of Qingdao University
Qingdao, China, 266003
Actively Recruiting
12
Qinghai People's Hospital
Qinghai, China, 810007
Actively Recruiting
13
Yuncheng Central Hospital
Yuncheng, China, 044099
Actively Recruiting
Research Team
Y
Yan Wang
Z
Zikun Ma
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here