A Diagnostic Study on Patients With Drug-induced Liver Injury

A Multi-center, Prospective Cohort Study on the Diagnostic Value and Prognostic Factors of the RUCAM Scale in Patients With Acute Drug-induced Liver Injury Based on Chronic Liver Disease

This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.

Study Overview

• Status: Unknown
• Conditions: Chronic Liver Disease; Acute Drug-induced Liver Injury

Detailed Description

This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.

This research will propose a new or optimized DILI diagnostic scheme based on the analysis of the problems existing in the practice of RUCAM scale, the clinical characteristics and prognosis of DILI, the exploration of biomarkers, and all the comprehensive information of big data from Hepatox platform, and establish a big data-based diagnosis model or auxiliary diagnosis decision system.

• Study Type: Observational
• Enrollment (Anticipated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with acute drug-induced liver injury

Description

Inclusion Criteria:

• No restriction on age and gender.

• Patients need to meet one of the following biochemical thresholds for acute liver injury recommended by the international consensus:

  1. ALT < 5 x ULN
  2. ALP < 2 x ULN
  3. ALT 3 ULN and TBIL 2 ULN
• The duration of liver biochemical abnormalities does not exceed 90 days.
• For the clinical diagnosis of acute drug-induced liver injury, the RUCAM scale ≥ 6 points is required. However, if the RUCAM scale score is 3-5 points, the opinions of 3 experts are needed to confirm the diagnosis of DILI, and the patients can only be enrolled after the experts agree to it.
• The patient signs the informed consent form after fully understanding the nature of the study, the nature of his/her disease, related treatment methods, and the potential risks associated with participating in the trial.

Exclusion Criteria:

• Non-drug induced liver injury
• An inability to complete the visits prescribed by the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical symptoms and signs	fatigue, anorexia, abdominal distention, jaundice, nausea, vomiting, gingival bleeding, epistaxis, liver pain, hepatomegaly, splenomegaly, fever, rashes, joint pain, skin itching, etc.	6 months
Adverse events	Adverse events, severity and time	6 months
ALT	U/L	6 months
ALP	U/L	6 months
TBIL	umol/L	6 months

Collaborators and Investigators

• Sponsor: Drug Induced Liver Disease Study Group

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Poisoning; Liver Diseases; Wounds and Injuries; Chemical and Drug Induced Liver Injury
• Other Study ID Numbers: CR2020DILI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No