Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes.
Feng-Qin Hou, Zheng Zeng, Gui-Qiang Wang
https://pubmed.ncbi.nlm.nih.gov/22806342Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06922669
Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial
Led by General Hospital of Shenyang Military Region · Updated on 2025-12-18
232
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates drug-induced liver injury (DILI) with hyperbilirubinemia, a condition that can cause serious complications like acute liver failure and death. Researchers aim to explore the efficacy and safety of glucocorticoids in treating acute DILI patients with elevated bilirubin levels through a multicenter randomized controlled trial. The study addresses the limited and controversial evidence regarding glucocorticoid use for this condition. A total of 232 patients will be randomly assigned to receive either conventional treatment alone or conventional treatment combined with glucocorticoids. The glucocorticoid treatment involves an initial intravenous dose of methylprednisolone for one week, possibly extended to two, followed by a tapered oral dose over one to three months. Conventional treatments include various liver-supporting drugs, and additional procedures like plasma exchange or liver transplantation may be used if the liver condition worsens. Participants will be closely monitored with evaluations at two and four weeks for liver injury improvement and enzyme levels, along with tracking progressive liver injury, liver failure, transplantation, survival, and adverse events up to three months. The study also explores inflammatory changes and identifies which patients might benefit from glucocorticoid therapy. Total participation spans from enrollment through three months of follow-up.
CONDITIONS
Brief Title
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- A definite diagnosis of acute drug-induced liver injury (DILI)
- Total bilirubin (TBIL) level between 5×ULN and 20×ULN at baseline
- Age between 18 and 80 years old
- Signed informed consent form
You will not qualify if you...
- Liver injury caused by viral hepatitis, cytomegalovirus, Epstein-Barr virus, Herpes virus, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, or α1-antitrypsin deficiency
- DILI caused by immune checkpoint inhibitors or gynura segetum
- Absolute contraindications to glucocorticoids such as systemic mold infections or allergies
- History of glucocorticoid therapy within 3 months before enrollment
- History of diseases needing glucocorticoid maintenance therapy like rheumatoid arthritis, systemic lupus erythematosus, or systemic dermatomyositis
- History of liver transplantation
- Received artificial liver therapy before enrollment
- Malignant tumors of the liver, bile duct, pancreas, or liver metastasis
- Acute liver failure
- Renal dysfunction with creatinine ≥133 µmol/L
- Neutrophil count below 1,000,000,000/L
- Active tuberculosis
- Severe heart or lung diseases
- Recent surgery or trauma
- Mental illness
- Pregnancy or breastfeeding
- Participation in other clinical studies within 3 months before enrollment
- Other conditions deemed inappropriate by the clinician for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 to 3 months
Participants receive either glucocorticoids combined with conventional treatment or conventional treatment alone for acute drug-induced liver injury. This includes an initial intravenous dose of methylprednisolone for up to two weeks, followed by oral methylprednisolone tapered over 1 to 3 months, alongside other conventional drug therapies.
Weekly visits for up to 4 weeks, then periodic visits during tapering
Follow-up
Duration - Up to 3 months
Participants are monitored for clinical outcomes including liver function improvement, adverse events, and survival up to three months after treatment initiation.
Visits up to 3 months for monitoring
Trial Site Locations
Total: 1 location
1
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China, 110840
Actively Recruiting
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Research Team
X
Xingshun Qi
Q
Qianqian Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Beneficial effect of corticosteroids for patients with severe drug-induced liver injury.
Ping Fang Hu, Pei Qin Wang, Han Chen...
https://pubmed.ncbi.nlm.nih.gov/27426618Successful corticosteroid therapy for severe liver injury secondary to herbal traditional Chinese medicine, Mega Defends X, assessed for causality by the updated RUCAM: A case report.
Lu Chai, Ran Wang, Rolf Teschke...
https://pubmed.ncbi.nlm.nih.gov/39183394Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update.
Yimin Mao, Shiwu Ma, Chenghai Liu...
https://pubmed.ncbi.nlm.nih.gov/38402364Efficacy and safety of glucocorticoids for acute drug-induced liver injury with hyperbilirubinemia: protocol of a multicenter randomized controlled trial.
Qianqian Li, Yong Lin, Xin Zeng...
https://pubmed.ncbi.nlm.nih.gov/42080196