A Diagnostic Study on Patients With Drug-induced Liver Injury

NCT04526548 | Unknown

• 1 other identifier: CR2020DILI
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Drug-induced Liver Injury; Chronic Liver Disease

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute drug-induced liver injury

You may qualify if:

• 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:
• ALT \< 5 x ULN
• ALP \< 2 x ULN
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Drug Induced Liver Disease Study Group: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 26, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 27, 2020

Record last verified: 2020-08