Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

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.

Conditions

• Drug Induced Liver Injury

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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region

  lead OTHER

Principal Investigators

• Xingshun Qi · Department of Gastroenterology, General Hospital of Northern Theater Command

• Weifen Xie · Shanghai changzheng hospital, Naval Medical University

• Xin Zeng · Shanghai East Hospital,Tongji University School of Medicine

• Lu Zhou · General Hospital, Tianjin Medical University

• Fengmei Wang · Tianjin First Central Hospital

• Qing Ye · Tianjin Third Central Hospital

• Yanjing Gao · Qilu Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-24

Primary Completion

2027-03-31

Completion

2027-09-30

Countries

• China

Study Locations