Primary Biliary Cholangitis
Conditions
Brief summary
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.
Detailed description
By focusing on invasive markers like aspartate aminotransferase to platelet ratio index (APRI), enhanced liver fibrosis (ELF), 7-hydroxy-4-cholesten-3-one (C4), and fibroblast growth factor 19 (FGF19), the study will help understand the multifaceted impact of the treatment on liver fibrosis, extracellular matrix turnover, inflammation, and bile acid metabolism. This approach will ultimately guide better clinical management of PBC, allowing for tailored treatment strategies and improved patient outcomes. The objective of this study is to evaluate the effectiveness of combined ursodiol and seladelpar treatment in PBC patients by monitoring changes in APRI, ELF score, and FGF19 levels, and validate results using traditional methods over 36 months.
Interventions
PROCEDUREBlood Draws
Research-related blood draws will be used to ascertain FGF19 levels.
Sponsors
Methodist Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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. * Patients must be willing and able to provide written informed consent for participation in the study.
Exclusion criteria
* 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. * Patients with significant comorbid conditions that may interfere with the study outcomes, such as severe cardiovascular, renal, or pulmonary diseases. * Pregnant or breastfeeding women, due to potential risks to the fetus or infant. * Inability or unwillingness to comply with the study protocol, including scheduled visits, tests, and procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALP and bilirubin levels | through study completion, up to 18 months | Pruritus severity using the pruritus numeric rating scale |
Contacts
Primary ContactJeffrey Wilson
Backup ContactKarshena Valsin
Outcome results
None listed