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Search / Trial NCT06922669

Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

Launched by GENERAL HOSPITAL OF SHENYANG MILITARY REGION · Apr 3, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Drug Induced Liver Injury Liver Failure Glucocorticoids Clinical Trial Hyperbilirubinemia

ClinConnect Summary

This clinical trial is investigating the use of glucocorticoids, a type of medication that can reduce inflammation, for patients suffering from acute drug-induced liver injury (DILI) who also have high bilirubin levels (hyperbilirubinemia). DILI can be serious and may lead to liver failure, so researchers want to understand if glucocorticoids can help improve patient outcomes. The trial will involve multiple medical centers and aims to find out if this treatment is both effective and safe for these patients.

To participate in this trial, individuals need to be between 18 and 80 years old and must have a clear diagnosis of acute DILI, with specific bilirubin levels indicating their condition. However, there are several criteria that may exclude someone from participating, such as having other types of liver disease or serious health issues that could complicate treatment. Participants will need to sign an informed consent form, which means they agree to take part in the study after being fully informed about what it involves. This trial is not yet recruiting participants, but it represents an important step in understanding how to treat a challenging medical condition.

Gender

ALL

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.

About General Hospital Of Shenyang Military Region

The General Hospital of Shenyang Military Region is a leading medical institution in China, dedicated to advancing healthcare through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive resources and expertise to explore new therapeutic interventions and improve patient outcomes. Committed to upholding the highest ethical standards and regulatory compliance, the hospital fosters collaboration among multidisciplinary teams to drive scientific discovery and enhance the quality of care within military and civilian populations.

Locations

Shenyang, Liaoning, China

Patients applied

0 patients applied

Trial Officials

Xingshun Qi

Principal Investigator

Department of Gastroenterology, General Hospital of Northern Theater Command

Weifen Xie

Principal Investigator

Shanghai changzheng hospital, Naval Medical University

Xin Zeng

Principal Investigator

Shanghai East Hospital,Tongji University School of Medicine

Lu Zhou

Principal Investigator

General Hospital, Tianjin Medical University

Fengmei Wang

Principal Investigator

Tianjin First Central Hospital

Qing Ye

Principal Investigator

Tianjin Third Central Hospital

Yanjing Gao

Principal Investigator

Qilu Hospital of Shandong University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported