Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Recruiting now · Not applicable
Conditions studied: Drug Induced Liver Injury
In brief
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.
Key facts
- Study ID
- NCT06922669
- Run by
- General Hospital of Shenyang Military Region
- People needed
- 232
- Starts
- 2025-06-24
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A definite diagnosis of acute DILI;
- 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
- Age 18-80 years old;
- Sign the informed consent form.
You may not qualify if…
- 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.
Where it is running
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) — Shenyang, Liaoning, China (enrolling)
Full record on ClinicalTrials.gov
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