Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury

NCT ID: NCT06547229

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2028-06-30

Brief Summary

The goal of this observational study is to screening for clinical, pathological and HLA features in patients with recurrent drug-induced liver injury. The main question it aims to answer is: Which patients with drug-induced liver injury need to be more cautious when re-dosing?

Detailed Description

Research Objectives:

1. To summarise the clinicopathological characteristics of patients with recurrent drug-induced liver injury (DILI) in the Liver Disease Centre of Beijing Friendship Hospital in the past 10 years.

2. Compare the differences in clinicopathological characteristics between patients with only one episode of different drug use and those with recurrent DILI, and predict the risk/protective factors in patients with recurrent DILI.

3. Explore the susceptibility genes in patients with recurrent DILI.

Conditions

Recurrent Drug-induced Liver Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

1. Liver enzymes returns to normal or has a tendency to remission after the first drug liver injury;

2. Signs and symptoms of liver injury after the patient takes the different drugs for liver injury again, and the liver enzymes returns to normal through follow-up.

1. RUCAM ≥6 and met one of the following biochemical conditions: (1)ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.

2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.

3. Onset to enrollment ≤3 months.

Exclusion Criteria

• 1. Hepatotropic viral infection: hepatitis A, B, C, D and E. 2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.

3. Hypoxic ischemic hepatitis and congestive liver disease. 4. Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.

6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG)simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.

7. Parasitic infection. 8. Sepsis. 9. Previous liver transplantation or bone marrow transplantation. 10. Pregnancy or lactation. 11. Genetic and metabolic liver diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Xinyan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinyan Zhao

Role: STUDY_CHAIR

Beijing Friendship Hospital

Locations

Liver Research Center, Beijing Friendship Hospital, Key Laboratory on Translational Medicine on Cirrhosis, National Clinical Research Center for Digestive Disease, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2024-P2-238

Identifier Type: -

Identifier Source: org_study_id