Actively Recruiting

Age: 18Years +
All Genders
NCT05060289

A Prognostic Model for Drug-induced Liver Injury in China

Led by Beijing Friendship Hospital · Updated on 2025-09-22

3000

Participants Needed

13

Research Sites

344 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

A Prognostic Model for Drug-induced Liver Injury in China

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • RUCAM score 6 or higher with at least one of these: ALT at least 5 times the upper limit of normal (ULN), ALP at least 2 times ULN, or ALT at least 3 times ULN and total bilirubin (TBil) at least 2 times ULN
  • RUCAM score between 3 and 5 with diagnosis agreed by at least 4 out of 5 experienced hepatologists
  • Onset of liver injury symptoms within 3 months before enrollment
Not Eligible

You will not qualify if you...

  • Infection with hepatitis A, B, C, D, or E viruses
  • Infection with non-hepatotropic viruses like cytomegalovirus or Epstein-Barr virus
  • Hypoxic ischemic hepatitis or congestive liver disease
  • Alcohol consumption over 40g/day for males or 20g/day for females for 5 or more years
  • Biliary obstruction, primary biliary cholangitis, or primary sclerosing cholangitis
  • Autoimmune hepatitis with specific diagnostic scores or unclear differentiation
  • Parasitic infection
  • Sepsis
  • Previous liver or bone marrow transplantation
  • Pregnancy or breastfeeding
  • Genetic or metabolic liver diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

Y

Yan Wang

CONTACT

Z

Zikun Ma

CONTACT

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

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