Monitoring the Response of Combination Ursodiol and Seladelpar Treatment
ConditionPrimary Biliary Cholangitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMethodist Health System
About this trial
This study aims to provide comprehensive insights into the therapeutic effects of combination treatment with ursodiol and seladelpar in PBC patients by assessing biochemical responses using biomarkers such as ALP and total bilirubin.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have a confirmed diagnosis PBC as per established diagnostic criteria.
Adults aged 18 years and older.
Patients undergoing treatment with ursodiol (ursodeoxycholic acid) for PBC or who demonstrate intolerance to ursodiol due to side effects and persistent ALP > normal.
Patients undergoing treatment with seladelpar for PBC.
Disqualifiers
Patients that do not meet inclusion criteria.
Patients with other chronic liver diseases, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis (NASH), alcoholic liver disease, or other autoimmune liver diseases.
Patients who have undergone a liver transplant.
Presence of cirrhosis or hepatic decompensation at the time of study enrollment.
Trial population
A cohort of 100 PBC patients treated with ursodiol and seladelpar
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood Draws
Procedure/SurgeryResearch-related blood draws will be used to ascertain FGF19 levels.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
ALP and bilirubin levels
Pruritus severity using the pruritus numeric rating scale
Time frame
through study completion, up to 18 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: