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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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.

Detailed Summary:

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

  1. assess the DILI patients' clinical outcomes and influencing factors in the real world;
  2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Secondary objectives

  1. assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.;
  2. evaluate the histological features of DILI patients;
  3. assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)

Sponsor: Drug Induced Liver Disease Study Group

Current Primary Outcome: Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Drug Induced Liver Disease Study Group

Dates:
Date Received: October 24, 2016
Date Started: April 2016
Date Completion: July 2017
Last Updated: March 27, 2017
Last Verified: March 2017