Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• A definite diagnosis of acute DILI;
• 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
• Age 18-80 years old;
• Sign the informed consent form.
Locations
Other Locations
China
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
RECRUITING
Shenyang
Contact Information
Primary
Xingshun Qi
xingshunqi@126.com
18909881019
Backup
Qianqian Li
1208594776@qq.com
13940307473
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 232
Treatments
Experimental: Glucocorticoids group
Glucocorticoids step-down therapy combined with conventional treatment.
Active_comparator: Conventional treatment
Only conventional treatment according to the Chinese practice guidelines regarding the management of DILI.
Related Therapeutic Areas
Sponsors
Leads: General Hospital of Shenyang Military Region