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

Li Yang

Status and phase: Enrolling; Phase 4

Conditions: Drug-induced Liver Injury

Treatments: Drug: Glucocorticoids+hepatoprotectant; Drug: hepatoprotectant

Study type: Interventional

Funder types: Other

Identifiers

NCT04553003

LYang

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

glucocorticoid+hepatoprotectant group

Experimental group

Description:

glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d

Treatment:

Drug: Glucocorticoids+hepatoprotectant

hepatoprotectant group

Active Comparator group

Description:

hepatoprotectant for 7d

Treatment:

Drug: hepatoprotectant