Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial

Phase 4

Recruiting

• Conditions: Drug-induced Liver Injury
• Interventions: Drug: hepatoprotectant; Drug: Glucocorticoids+hepatoprotectant

• Registration Number: NCT04553003
• Lead Sponsor: Li Yang

Brief Summary

The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-30
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Clinical diagnosis of DILI

2. RUCAM score≥6 and with liver histology

3. Meet any of the following conditions:

   1. TBIL ≥ 10 fold ULN ;
   2. TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN

Exclusion Criteria

1. An chronic onset (≥6 months)
2. Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
3. with contraindications of glucocorticoid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hepatoprotectant group	hepatoprotectant	hepatoprotectant for 7d
glucocorticoid+hepatoprotectant group	Glucocorticoids+hepatoprotectant	glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d

Primary Outcome Measures

Name	Time	Method
percentage of patients that AST or ALT decline 25% at day 4	Change from Baseline ALT and AST at day4	AST or ALT decline 25% at day 4

Secondary Outcome Measures

Name	Time	Method
percentage of patients that AST or ALT decline 50% at day 8	Change from Baseline ALT and AST at day8	AST or ALT decline 25% at day 8
the time needed when TBIL decline 50%	up to 2 weeks	TBIL decline 50%; time
relapse rate in 12 months after drug withdrawal	12 months after drug withdrawal	relapse rate
mortality in 12 months after drug withdrawal	12 months after drug withdrawal	mortality
incidence of side effects	up to 2 years	infection，uncontrolled hypertension or hyperglycemia

Trial Locations

Locations (1)

Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University; 🇨🇳 Chengdu, Sichuan, China