CompletedPhase 1/2

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

China80 participantsStarted 2015-12

Plain-language summary

This study is to observe the efficacy and safety of glucocorticosteroid treatment in the patients with chronic recurrent drug-induced liver injury (DILI).

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
✓. Meet any of the following conditions:
✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

The relapse or recurrent rate of illness, namely, appearance of obviously abnormal liver function again during treatment and follow-up period

Timeframe: At week 24

The relapse or recurrent rate of illness, namely, appearance of obviously abnormal liver function again during treatment and follow-up period

Timeframe: At week 72

Trial details

NCT IDNCT02651350

SponsorBeijing 302 Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07

View on ClinicalTrials.gov More Drug-induced Liver Injury,Chronic trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
✓. Meet any of the following conditions:
✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

The relapse or recurrent rate of illness, namely, appearance of obviously abnormal liver function again during treatment and follow-up period

Timeframe: At week 24

The relapse or recurrent rate of illness, namely, appearance of obviously abnormal liver function again during treatment and follow-up period

Timeframe: At week 72