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

Li Yang80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug-induced Liver Injury

Interventions

Glucocorticoids+hepatoprotectantDRUG

Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.

hepatoprotectantDRUG

Participants received hepatoprotectants (i.v.gtt.) for 7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

percentage of patients that AST or ALT decline 25% at day 4

AST or ALT decline 25% at day 4

Time frame: Change from Baseline ALT and AST at day4

Secondary Outcomes

percentage of patients that AST or ALT decline 50% at day 8

AST or ALT decline 25% at day 8

Time frame: Change from Baseline ALT and AST at day8

the time needed when TBIL decline 50%

TBIL decline 50%; time

Time frame: up to 2 weeks

incidence of side effects

infection，uncontrolled hypertension or hyperglycemia

Time frame: up to 2 years

relapse rate in 12 months after drug withdrawal

relapse rate

Time frame: 12 months after drug withdrawal

mortality in 12 months after drug withdrawal

mortality

Time frame: 12 months after drug withdrawal

Data from ClinicalTrials.gov

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