Clinical trial NCT06547229: Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury
Official title: Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Recurrent Drug-induced Liver Injury
Keywords: Genetic Susceptibility
HLA
Endpoint Event(s)
Drug-induced Liver Injury
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult with recurrent drug-induced liver injury

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for recurrent drug induced liver injury:

  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.

Inclusion criteria for drug induced liver injury:

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.

Primary outcomes:
measure: Death/Liver transplantation
timeFrame: 1 year
measure: Acute Liver Failure
timeFrame: 1 year
measure: Recovery
timeFrame: 1 year
Secondary outcomes:
measure: chronic DILI
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Xinyan Zhao
role: STUDY_CHAIR
References: