Monitoring the Response of Combination Ursodiol and Seladelpar Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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

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Primary Biliary Cholangitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood Draws

Research-related blood draws will be used to ascertain FGF19 levels.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No