Status:
COMPLETED
36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent DILI
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Drug-induced Liver Injury,Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is to observe the efficacy and safety of 36 weeks short-term optimization treatment of glucocorticosteroid in the patients with chronic recurrent drug-induced liver injury (DILI).
Detailed Description
Drug-induced liver injury (DILI) refers to liver diseases caused by drugs and toxic substances. DILI is a clinical event that can be associated with severe outcomes such as acute liver failure. Up to ...
Eligibility Criteria
Inclusion
- Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
- The time of recurrence is 1 or more than 1;
- The definition of recurrence, meet any of the following conditions:
- the level of serum AST or ALT is elevated more than 5 fold ULN;
- the level of serum AST or ALT is two times higher than before;
- Meet any of the following conditions:
- serum AST or ALT ≥ 10 fold ULN;
- serum AST or ALT ≥ 5 fold ULN and TBIL ≥ 2 fold ULN;
- liver histology indicates bridging necrosis or multiacinar necrosis or moderate or more inflammation or inflammation G3 or more;
- Women of childbearing age had a negative urine pregnancy test, and the subjects are willing to have no family planning during the study and to take effective measures;
- Voluntary participation, understanding and signing of informed consent, comply with the requirements of the research.
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Exclusion
- Patients with serious pre-existent comorbid conditions (vertebral compression fractures,psychosis,active peptic ulcer, brittle diabetes,uncontrolled hypertension;
- Patients with intolerances to prednisone;
- Patients with severe infection receiving antibiotics, anti-fungal,anti-viral therapy;
- Viral hepatitis,alcoholic or non-alcoholic liver disease,Wilson's disease or other inherited metabolic liver diseases.
- Pregnancy or desire of pregnancy;
- Breast-feeding;
- Liver cancer or other malignant tumor.
Key Trial Info
Start Date :
September 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03266146
Start Date
September 2 2017
End Date
January 31 2023
Last Update
February 15 2023
Active Locations (1)
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1
Beijing 302 hospital
Beijing, China, 100039