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

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Li Yang
• Treatments: Choline; Glucocorticoids; Methylprednisolone; Polyene phosphatidylcholine; Prednisone

Criteria

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