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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xingshunqi@126.com
• Phone: 18909881019

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Observational study on drug-induced liver injury in China

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• Registry for patients with drug-induced liver injury

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.