NCT07122206

Monitoring the Response of Combination Ursodiol and Seladelpar Treatment

Monitoring the Response of Combination Ursodiol and Seladelpar Treatment in Primary Biliary Cholangitis Using Invasive Markers

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
PROCEDURE	Blood Draws	Research-related blood draws will be used to ascertain FGF19 levels.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-08-14
• Last updated: 2025-08-14