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Not yet recruitingNCT07122206Updated Aug 14, 2025

Monitoring the Response of Combination Ursodiol and Seladelpar Treatment

An observational study in Primary Biliary Cholangitis, sponsored by Methodist Health System. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Biliary Cholangitis
03

In context

Liver Cirrhosis, Biliary

208 studies on the registry are indexed under Liver Cirrhosis, Biliary; 44 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 49 observational studies indexed under Liver Cirrhosis, Biliary.

Browse Liver Cirrhosis, Biliary studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

A cohort of 100 PBC patients treated with ursodiol and seladelpar

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedureBlood Draws

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

06

What researchers measure

Primary outcomes

  1. ALP and bilirubin levels

    Pruritus severity using the pruritus numeric rating scale

    Time frame: through study completion, up to 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07122206
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Aug 14, 2025
Start date
Aug 2025 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 14, 2025

Study contacts

Jeffrey Wilson
Contact
JeffreyWilson@mhd.com
7373332427
Karshena Valsin
Contact
KarshenaValsin@mhd.com
2149474681
Mangesh Pagadala, MD
principal investigator · Methodist Heath System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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