Monitoring the Response of Combination Ursodiol and Seladelpar Treatment

Methodist Health System

Status: Not yet enrolling

Conditions: Primary Biliary Cholangitis

Treatments: Procedure: Blood Draws

Study type: Observational

Funder types: Other

Identifiers

NCT07122206

031.HEP.2024.D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.