Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial

General Hospital of Shenyang Military Region1 个研究点分布在 1 个国家目标入组 232 人开始时间: 2025年6月24日最近更新: 2025年12月18日

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 232
试验地点: 1
主要终点: Improvement of DILI on the second week

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.

详细描述

Overall, 232 patients with acute DILI with hyperbilirubinemia will be enrolled. They will be randomly assigned at a ratio of 1:1 to the conventional treatment alone or combined with glucocorticoids groups. The primary endpoint is the improvement of DILI after treatment on second week. Secondary endpoints include the improvement of DILI on fourth week, rates of progressive liver injury, liver failure, liver transplantation, survival, and adverse events. Exploratory endpoints will assess the beneficial population and changes of inflammatory factors following glucocorticoid treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•A definite diagnosis of acute DILI;
•5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
•Age 18-80 years old;
•Sign the informed consent form.

排除标准

•Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;
•Immune checkpoint inhibitors or gynura segetum induced DILI;
•Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;
•A history of glucocorticoid therapy within 3 months before enrollment;
•A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;
•A history of liver transplantation;
•Received artificial liver therapy before enrollment;
•Malignant tumor of the liver, bile duct, pancreas or liver metastasis
•Acute liver failure;
•Renal dysfunction, creatinine Cr≥133μmol/L;
•Neutrophil count <1,000,000,000/L;
•Active tuberculosis;
•Severe cardiopulmonary diseases;
•Recent surgery or trauma;
•Mental illness;
•Pregnancy or lactation;
•Participated in other clinical studies within 3 months before enrollment;
•Other conditions judged by the clinician to be inappropriate for study participation.

研究组 & 干预措施

Conventional treatment

Active Comparator

Only conventional treatment according to the Chinese practice guidelines regarding the management of DILI.

干预措施: Silymarin (Drug)