Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial
General Hospital of Shenyang Military Region
232 participants
Jun 24, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Initially, an intravenous dose of 1 mg/kg/day of methylprednisolone will be administered for one week, with the possibility of extending treatment to two weeks if necessary. Following this, participants will receive oral methylprednisolone tablets, starting at a dose of 40 mg/day. The oral dosage will be gradually tapered based on the participants' condition over a period of 1 to 3 months.
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06922669