Monitoring the Response of Combination Ursodiol and Seladelpar Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Draws.
- Who it may be relevant to
- Registry conditions: Primary Biliary Cholangitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monitoring the Response of Combination Ursodiol and Seladelpar Treatment in Primary Biliary Cholangitis Using Invasive Markers
Overview
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.
Interventions
- Procedure Blood Draws
Research-related blood draws will be used to ascertain FGF19 levels.
Primary outcome measures
- ALP and bilirubin levels [Time frame: through study completion, up to 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07122206 · 031.HEP.2024.D