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

NCT04553003 | Unknown Phase 4

• 1 other identifier: LYang
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug-induced Liver Injury

Keywords

glucocorticosteroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Change from Baseline ALT and AST at day8

• the time needed when TBIL decline 50%

  up to 2 weeks

• incidence of side effects

  up to 2 years

• relapse rate in 12 months after drug withdrawal

  12 months after drug withdrawal

• mortality in 12 months after drug withdrawal

  12 months after drug withdrawal

Study Arms (2)

glucocorticoid+hepatoprotectant group

EXPERIMENTAL

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

Drug: Glucocorticoids+hepatoprotectant

hepatoprotectant group

ACTIVE COMPARATOR

hepatoprotectant for 7d

Drug: hepatoprotectant

Interventions

Glucocorticoids+hepatoprotectant DRUG

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

Also known as: prednisone, methylprednisolone

glucocorticoid+hepatoprotectant group

hepatoprotectant DRUG

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

Also known as: Ademetionine1,4-Butanedisulfonate, Polyene Phosphatidyl choline

hepatoprotectant group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of DILI
• RUCAM score≥6 and with liver histology
• Meet any of the following conditions:
• TBIL ≥ 10 fold ULN ;
• TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN

You may not qualify if:

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

Sponsors & Collaborators

• Li Yang: lead

Study Sites (1)

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

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

Prednisone; Methylprednisolone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prednisolone; Pregnadienetriols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 17, 2020
• Study Start: August 1, 2020
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)