36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent DILI

• Status: Active, not recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing 302 Hospital
• Treatments: Alprostadil; Glucocorticoids; 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. 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;

3. 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;

4. 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;

5. Voluntary participation, understanding and signing of informed consent, comply with the requirements of the research.

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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.