RecruitingNot ApplicableNCT06922669

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


Sponsor

General Hospital of Shenyang Military Region

Enrollment

232 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • A definite diagnosis of acute DILI;
  • ×ULN ≤ TBIL level at baseline ≤ 20×ULN;
  • Age 18-80 years old;
  • Sign the informed consent form.

Exclusion Criteria18

  • 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.

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Interventions

DRUGMethylprednisolone

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.

DRUGMagnesium isoglycyrrhizinate

It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g

DRUGGlutathione

It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g

DRUGSilymarin

It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.

DRUGPolyene Phosphatidylcholine

It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.

DRUGUrsodeoxycholic acid capsules

It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.

DRUGAdemetionine 1,4-Butanedisulfonate

It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.

PROCEDUREPlaslna exchange

It is suitable for patients whose condition continues to worsen or even develop to liver failure.

PROCEDURELiver 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

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NCT06922669