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Clinical Trial NCT05256979 (URSO) for Non-Alcoholic Fatty Liver Disease is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation (URSO) 20 Non-Invasive Observational
Clinical Trial NCT05256979 (URSO) is an observational study for Non-Alcoholic Fatty Liver Disease that is active, not recruiting. It started on 2 July 2022 with plans to enroll 20 participants. Led by General University Hospital, Prague, it is expected to complete by 30 June 2025. The latest data from ClinicalTrials.gov was last updated on 17 March 2025.
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 6month period. Laboratory parameters, non-invasive indices, liver elastography, cardiovascular parameters and liver MR spectroscopy will be performed.
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 elastography will be performed. Non-invasive indices evaluating liver fibrosis and steatosis based on common anthropometric and laboratory parameters (FLI, NAFLD fibrosis score, BARD score, APRI, FIB-4) will also be evaluat...Show More
Official Title
Clinical Observation of the Effect of Ursodeoxycholic Acid on Parameters Affecting Liver, Metabolic and Cardiovascular Morbidity and Mortality - Pilot Project
Conditions
Non-Alcoholic Fatty Liver DiseasePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- URSO
- GUHPrague
NCT ID Number
Start Date (Actual)
2022-07-02
Last Update Posted
2025-03-17
Completion Date (Estimated)
2025-06-30
Enrollment (Estimated)
20
Study Type
Observational
Status
Active, not recruiting
Keywords
NAFLD
Liver steatosis
Liver fibrosis
Ursodeoxycholic acid
Liver steatosis
Liver fibrosis
Ursodeoxycholic acid
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The effect of urso on GGT | The effect of UDCA therapy on GGT activity (ukat/l; change from baseline). | 6 months |
The effect of urso on liver fat content | The effect of UDCA therapy on liver fat content measured by MR spectroscopy (percentual change from baseline). | 6 months |
The effect of urso on cardiovascular parameters - carotid intima media | The effect of UDCA therapy on carotid intima media thickness measured by ultrasound (change in mm from the baseline) | 6 months |
The effect of urso on cardiovascular parameters - endothelial dysfunction | The effect of UDCA therapy on endothelial dysfunction measured in percentual change in ENDO-PAT examination. | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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").
- 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.
General University Hospital, PragueStudy Responsible Party
Radan Bruha, Principal Investigator, Principal Investigator, General University Hospital, Prague
No contact data.
1 Study Locations in 1 Countries
General University Hospital, Prague, 12808, Czechia