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

NCT ID: NCT04553003

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-04-01

Brief Summary

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

Detailed Description

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Conditions

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Drug-induced Liver Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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glucocorticoid+hepatoprotectant group

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

Group Type EXPERIMENTAL

Glucocorticoids+hepatoprotectant

Intervention Type DRUG

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

hepatoprotectant group

hepatoprotectant for 7d

Group Type ACTIVE_COMPARATOR

hepatoprotectant

Intervention Type DRUG

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

Interventions

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Glucocorticoids+hepatoprotectant

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

Intervention Type DRUG

hepatoprotectant

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

Intervention Type DRUG

Other Intervention Names

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prednisone methylprednisolone Ademetionine1,4-Butanedisulfonate Polyene Phosphatidyl choline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Li Yang

OTHER

Sponsor Role lead

Responsible Party

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Li Yang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Li Yang, MD

Role: primary

+86 18980601276

Yi Shen, MM

Role: backup

+86 18280097412

Other Identifiers

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LYang

Identifier Type: -

Identifier Source: org_study_id

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