Monitoring the Response of Combination Ursodiol and Seladelpar Treatment

NCT07122206 | Not Yet Recruiting

• 1 other identifier: 031.HEP.2024.D
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (1)

• ALP and bilirubin levels

  Pruritus severity using the pruritus numeric rating scale

  through study completion, up to 18 months

Interventions

Blood Draws PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of 100 PBC patients treated with ursodiol and seladelpar

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Methodist Health System: lead

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mangesh Pagadala, MD

  Methodist Heath System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Wilson

CONTACT

7373332427; JeffreyWilson@mhd.com

Karshena Valsin

CONTACT

2149474681; KarshenaValsin@mhd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share