Back to resultsGlucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
Primary Purpose
Drug-induced Liver Injury
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glucocorticoids+hepatoprotectant
hepatoprotectant
Sponsored by
About this trial
This is an interventional treatment trial for Drug-induced Liver Injury focused on measuring glucocorticosteroid
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- An chronic onset (≥6 months)
- Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
- with contraindications of glucocorticoid
Sites / Locations
- Division of Gastroenterology & Hepatology,West China Hospital,Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
glucocorticoid+hepatoprotectant group
hepatoprotectant group
Arm Description
glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d
hepatoprotectant for 7d
Outcomes
Primary Outcome Measures
percentage of patients that AST or ALT decline 25% at day 4
AST or ALT decline 25% at day 4
Secondary Outcome Measures
percentage of patients that AST or ALT decline 50% at day 8
AST or ALT decline 25% at day 8
the time needed when TBIL decline 50%
TBIL decline 50%; time
incidence of side effects
infection，uncontrolled hypertension or hyperglycemia
relapse rate in 12 months after drug withdrawal
relapse rate
mortality in 12 months after drug withdrawal
mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04553003
Brief Title
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
Official Title
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Yang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-induced Liver Injury
Keywords
glucocorticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
glucocorticoid+hepatoprotectant group
Arm Type
Experimental
Arm Description
glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d
Arm Title
hepatoprotectant group
Arm Type
Active Comparator
Arm Description
hepatoprotectant for 7d
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids+hepatoprotectant
Other Intervention Name(s)
prednisone, methylprednisolone
Intervention Description
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
Intervention Type
Drug
Intervention Name(s)
hepatoprotectant
Other Intervention Name(s)
Ademetionine1,4-Butanedisulfonate, Polyene Phosphatidyl choline
Intervention Description
Participants received hepatoprotectants (i.v.gtt.) for 7 days.
Primary Outcome Measure Information:
Title
percentage of patients that AST or ALT decline 25% at day 4
Description
AST or ALT decline 25% at day 4
Time Frame
Change from Baseline ALT and AST at day4
Secondary Outcome Measure Information:
Title
percentage of patients that AST or ALT decline 50% at day 8
Description
AST or ALT decline 25% at day 8
Time Frame
Change from Baseline ALT and AST at day8
Title
the time needed when TBIL decline 50%
Description
TBIL decline 50%; time
Time Frame
up to 2 weeks
Title
incidence of side effects
Description
infection，uncontrolled hypertension or hyperglycemia
Time Frame
up to 2 years
Title
relapse rate in 12 months after drug withdrawal
Description
relapse rate
Time Frame
12 months after drug withdrawal
Title
mortality in 12 months after drug withdrawal
Description
mortality
Time Frame
12 months after drug withdrawal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
An chronic onset (≥6 months)
Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
with contraindications of glucocorticoid
Facility Information:
Facility Name
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Phone
+86 18980601276
Email
yangli_hx@scu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yi Shen, MM
Phone
+86 18280097412
Email
156450779@qq.com
First Name & Middle Initial & Last Name & Degree
Yi Shen, MM
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
We'll reach out to this number within 24 hrs