Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05060289

A Prognostic Model for Drug-induced Liver Injury in China

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 .

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Drug-Induced Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing 302 Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Parasitic infection.
  • Sepsis.
  • Previous liver transplantation or bone marrow transplantation.
  • Pregnancy or lactation.
  • Genetic and metabolic liver diseases.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. chronic DILI

    Time frame: 2 years

    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.

  2. recovery

    Time frame: 2 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Wang

CONTACT

[email protected]

18810530724

Zikun Ma

CONTACT

[email protected]

18311270304

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study

Acronym: DILI-PM

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Sep 29, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.