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

April 28, 2022 updated by: Li Yang
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: glucocorticoid+hepatoprotectant group
glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d
Drug: Glucocorticoids+hepatoprotectant
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
Other Names:
  • methylprednisolone
  • prednisone
Active Comparator: hepatoprotectant group
hepatoprotectant for 7d
Drug: hepatoprotectant
Participants received hepatoprotectants (i.v.gtt.) for 7 days.
Other Names:
  • Ademetionine1,4-Butanedisulfonate
  • Polyene Phosphatidyl choline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of patients that AST or ALT decline 25% at day 4
Time Frame: Change from Baseline ALT and AST at day4
AST or ALT decline 25% at day 4
Change from Baseline ALT and AST at day4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Yang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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