NCT05256979Active, not recruiting
Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation
Clinical Observation of the Effect of Ursodeoxycholic Acid on Parameters Affecting Liver, Metabolic and Cardiovascular Morbidity and Mortality - Pilot Project
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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 6month period. Laboratory parameters, non-invasive indices, liver elastography, cardiovascular parameters and liver MR spectroscopy will be performed.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 8 Feb 2022
- Start date
- 2 Jul 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- General University Hospital, Prague
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05256979
What you commit to
- Study type: Observational
- Planned participants: 20
- From 2 Jul 2022 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with ursodeoxycholic acid.
Other illness
- 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.
Other
- Diagnosis of cirrhosis at the start of the study.
- Pregnancy.
Who the study is looking for
- 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").
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.