Status:
ACTIVE_NOT_RECRUITING
Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Recurrent Drug-induced Liver Injury
Eligibility:
All Genders
18+ years
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 pat...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria for recurrent drug induced liver injury:
- Liver enzymes returns to normal or has a tendency to remission after the first drug liver injury;
- 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.
- Inclusion criteria for drug induced liver injury:
- 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.
- 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.
- Onset to enrollment ≤3 months.
Exclusion
- 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.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06547229
Start Date
July 15 2024
End Date
June 1 2028
Last Update
August 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
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, 100050