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

Drug-induced Liver Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04553003
• Other study ID #: LYang
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2022
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug-induced Liver Injury
• Wounds and Injuries

Intervention

Drug:
• Glucocorticoids+hepatoprotectant
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
• hepatoprotectant
Participants received hepatoprotectants (i.v.gtt.) for 7 days.

Locations

Country	Name	City	State
China	Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Li Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients that AST or ALT decline 25% at day 4	AST or ALT decline 25% at day 4	Change from Baseline ALT and AST at day4
Secondary	percentage of patients that AST or ALT decline 50% at day 8	AST or ALT decline 25% at day 8	Change from Baseline ALT and AST at day8
Secondary	the time needed when TBIL decline 50%	TBIL decline 50%; time	up to 2 weeks
Secondary	incidence of side effects	infection,uncontrolled hypertension or hyperglycemia	up to 2 years
Secondary	relapse rate in 12 months after drug withdrawal	relapse rate	12 months after drug withdrawal
Secondary	mortality in 12 months after drug withdrawal	mortality	12 months after drug withdrawal