Status:
ACTIVE_NOT_RECRUITING
Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation
Lead Sponsor:
General University Hospital, Prague
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Brief Summary
Patients with NAFLD indicated for ursodeoxycholic acid treatment ("by SPC: cholestatic hepatitis") will be offered an observational study. Examinations will be performed before the treatment and after...
Detailed Description
Patients with NAFLD newly indicated for ursodeoxycholic acid treatment will be offered an observational study. Clinical examinations, blood sampling, ultrasound examinations of the liver and liver ela...
Eligibility Criteria
Inclusion
- Individuals with NAFLD with ALT elevation and cholestatic features who are indicated for standard treatment with ursodeoxycholic acid according to SPC ("Hepatitis of various etiologies with cholestatic syndrome").
Exclusion
- Previous treatment with ursodeoxycholic acid.
- Diagnosis of cirrhosis at the start of the study.
- Etiology of liver disease other than NAFLD.
- Presence of malignant disease.
- Cardiovascular comorbidity: CHD / CHD on pharmacological therapy, history of myocardial infarction, stroke and coronary / carotid intervention.
- Pregnancy.
Key Trial Info
Start Date :
July 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05256979
Start Date
July 2 2022
End Date
June 30 2025
Last Update
March 17 2025
Active Locations (1)
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1
General University Hospital
Prague, Czechia, 12808