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RECRUITING
NCT06922669
NA

Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

Sponsor: General Hospital of Shenyang Military Region

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2025-06-24

Completion Date

2027-09-30

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

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.

Locations (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China