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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shenyang, Liaoning, China
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