NCT06922669

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Drug Induced Liver Injury

Interventions

Type	Name	Description
DRUG	Methylprednisolone	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.
DRUG	Magnesium isoglycyrrhizinate	It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
DRUG	Glutathione	It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
DRUG	Silymarin	It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
DRUG	Polyene Phosphatidylcholine	It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
DRUG	Ursodeoxycholic acid capsules	It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
DRUG	Ademetionine 1,4-Butanedisulfonate	It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
PROCEDURE	Plaslna exchange	It is suitable for patients whose condition continues to worsen or even develop to liver failure.
PROCEDURE	Liver transplantation	It is suitable for patients whose condition continues to worsen or even develop to liver failure.

Timeline

• Start date: 2025-06-24
• Primary completion: 2027-03-31
• Completion: 2027-09-30
• First posted: 2025-04-10
• Last updated: 2025-12-18

Locations

1 site across 1 country: China