Cholestatic Drug-induced Liver Injury (DILI)
Hepatitis, Toxic
About this trial
This is an interventional treatment trial for Hepatitis, Toxic focused on measuring drug-induced liver injury, hepatitis, toxic, ursodeoxycholic acid
Eligibility Criteria
Inclusion Criteria:
- Drug-induced liver injury, meet the DILIN criteria.
Exclusion Criteria:
- Other systemic diseases may cause elevation of liver enzymes: viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, congestive heart failure, hypoxia, sepsis.
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
UDCA treatment
Placebo
Patients with drug-induced liver injury will be randomly allocated to UDCA treatment group: oral intake ursodeoxycholic acid (UDCA) 13-15 mg/kg BW/day into 3 divided doses after meal till the endpoint or the 8th week. UDCA is 100 mg per tab.
Patients with drug-induced liver injury will be randomly allocated to placebo group. The placebo is of the same color, size and shape as UDCA, and assumed 100 mg per tab. Patients in this group will orally intake 13-15 mg/Kg BW/day of placebo into 3 divided doses after meal as UDCA treatment group, till the endpoint or the 8th week.