A Diagnostic Study on Patients With Drug-induced Liver Injury

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04526548
• Other study ID #: CR2020DILI
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: October 2021

Study information

• Verified date: August 2020
• Source: Drug Induced Liver Disease Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 2021
• Est. primary completion date: April 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Drug-induced Liver Injury
• Chemical and Drug Induced Liver Injury
• Chronic Liver Disease
• Liver Diseases
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Drug Induced Liver Disease Study Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse events	Adverse events, severity and time	6 months
Primary	ALT	U/L	6 months
Primary	ALP	U/L	6 months
Primary	TBIL	umol/L	6 months