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
Qualifiers
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 design
Treatments tested in this trial
- Blood Draws
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov