Actively Recruiting
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Led by General Hospital of Shenyang Military Region · Updated on 2025-12-18
232
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A definite diagnosis of acute drug-induced liver injury (DILI)
- Total bilirubin level at baseline between 5×ULN and 20×ULN
- Age between 18 and 80 years old
- Signed informed consent form
You will not qualify if you...
- Other causes of liver injury such as 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, or α1-antitrypsin deficiency
- DILI caused by immune checkpoint inhibitors or gynura segetum
- Absolute contraindications to glucocorticoids like systemic mold infections or allergies
- History of glucocorticoid therapy within 3 months before enrollment
- History of diseases requiring glucocorticoid maintenance therapy such as rheumatoid arthritis, systemic lupus erythematosus, or systemic dermatomyositis
- History of liver transplantation
- Received artificial liver therapy before enrollment
- Malignant tumors of the liver, bile duct, pancreas, or liver metastasis
- Acute liver failure
- Renal dysfunction with creatinine ≥133 μmol/L
- Neutrophil count less than 1,000,000,000/L
- Active tuberculosis
- Severe heart or lung diseases
- Recent surgery or trauma
- Mental illness
- Pregnancy or lactation
- Participation in other clinical studies within 3 months before enrollment
- Other conditions considered inappropriate for participation by the clinician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China, 110840
Actively Recruiting
Research Team
X
Xingshun Qi
CONTACT
Q
Qianqian Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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