Overview

Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI

Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing 302 Hospital
Treatments:
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;