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NCT Number: NCT02961413

A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）

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.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji hospital

Shanghai, China

Location status: Recruiting

Location contact

Yimin Mao

CONTACT

About this study

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.)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • non-drug-induced liver injury

Treatment and study plan

Primary outcomes

  1. Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover

    Time frame: 6 months

Study contacts

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

Chunxia Zhang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Drug Induced Liver Disease Study Group

Other

Registry information

Official study title

A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China

Acronym: DILI-P

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Nov 11, 2016
Registry last updated
May 4, 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.

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