Overview
Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI
Status:
Completed
Completed
Trial end date:
2019-07-01
2019-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is to observe the efficacy and safety of glucocorticosteroid treatment in the patients with chronic recurrent drug-induced liver injury (DILI).Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Beijing 302 HospitalTreatments:
Alprostadil
Glycyrrhizic Acid
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Ursodeoxycholic Acid
Criteria
Inclusion Criteria:1. Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
2. 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;
3. 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;
4. Voluntary participation, understanding and signing of informed consent, comply with
the requirements of the research;
Exclusion Criteria:
1. Patients with serious pre-existent comorbid conditions (vertebral compression
fractures,psychosis,active peptic ulcer, brittle diabetes,uncontrolled hypertension;
2. Patients with intolerances to prednisone;
3. Patients with severe infection receiving antibiotics, anti-fungal,anti-viral therapy;
4. Viral hepatitis,alcoholic or non-alcoholic liver disease,Wilson's disease or other
inherited metabolic liver diseases.
5. Pregnancy or desire of pregnancy;
6. Breast-feeding;
7. Liver cancer or other malignant tumor;