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NCT Number: NCT06547229

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

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?

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Key information

Conditions

Recurrent Drug-induced Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Disease Attributes Disease Susceptibility Drug-Related Side Effects and Adverse Reactions Genetic Predisposition to Disease Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 100050, China

About this study

Research Objectives:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.
  • 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.
  • Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG)simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
  • Parasitic infection. 8. Sepsis. 9. Previous liver transplantation or bone marrow transplantation. 10. Pregnancy or lactation. 11. Genetic and metabolic liver diseases.

Treatment and study plan

Primary outcomes

  1. Death/Liver transplantation

    Time frame: 1 year

    DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) .

    DILI is the primary indication for liver transplantation.

  2. Acute Liver Failure

    Time frame: 1 year

    Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompaniedby mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.

  3. Recovery

    Time frame: 1 year

    Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanineaminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and totalbilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L).

Secondary outcomes

  1. chronic DILI

    Time frame: 2 years

    Chronicity is defined as the presence of any one of the following: (i) persistently elevated liver biochemistry indexes; (ii)radiological or histological evidence of persistent liver injury at one year after DILI onset.

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Acronym: RDILI-GS

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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