Treating acute drug-induced liver injury with high bilirubin using steroids

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

This trial will test whether adding glucocorticoid (steroid) treatment to standard care helps adults with acute drug‑induced liver injury and high bilirubin recover faster and avoid worsening liver problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06922669 on ClinicalTrials.gov

What this trial studies

This randomized trial will enroll about 232 adults with acute drug‑induced liver injury and markedly elevated bilirubin and randomly assign them 1:1 to standard medical treatment alone or standard treatment plus glucocorticoids. The primary outcome is improvement in liver injury at two weeks after treatment, with secondary outcomes measured at four weeks and including rates of progressive liver injury, liver failure, transplantation, survival, and adverse events. Exploratory analyses will look for which patients benefit most and changes in inflammatory markers after steroid treatment. Safety monitoring will track infections and other steroid‑related complications.

Who should consider this trial

Good fit: Adults aged 18–80 with a clear diagnosis of acute drug‑induced liver injury and total bilirubin between 5×ULN and 20×ULN, who have no alternative cause of liver injury and no contraindication to glucocorticoids, are the intended participants.

Not a fit: Patients with other identified causes of liver injury (viral, autoimmune, biliary, metabolic, ischemic, etc.), immune checkpoint inhibitor or gynura segetum–related DILI, prior/ongoing glucocorticoid therapy or conditions requiring maintenance steroids, prior liver transplant, or absolute contraindications to steroids are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding glucocorticoids could speed liver recovery and reduce progression to liver failure, transplantation, or death for patients with DILI and high bilirubin.

How similar studies have performed: Use of glucocorticoids in DILI with hyperbilirubinemia has been reported in clinical practice but high‑quality trial evidence is limited and results have been conflicting.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where this trial is running

Shenyang, Liaoning

• Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: Xingshun Qi — Department of Gastroenterology, General Hospital of Northern Theater Command
• Study coordinator: Xingshun Qi

Conditions: Drug Induced Liver Injury, Drug induced liver injury, liver failure, glucocorticoids, clinical trial, Hyperbilirubinemia