Status:
RECRUITING
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Lead Sponsor:
General Hospital of Shenyang Military Region
Conditions:
Drug Induced Liver Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 DI...
Detailed Description
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 gr...
Eligibility Criteria
Inclusion
- A definite diagnosis of acute DILI;
- 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
- Age 18-80 years old;
- Sign the informed consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
June 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT06922669
Start Date
June 24 2025
End Date
September 30 2027
Last Update
December 18 2025
Active Locations (1)
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1
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China, 110840