NCT07122206Not yet recruiting
Monitoring the Response of Combination Ursodiol and Seladelpar Treatment
Monitoring the Response of Combination Ursodiol and Seladelpar Treatment in Primary Biliary Cholangitis Using Invasive Markers
Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- Aug 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Methodist Health System
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07122206
What you commit to
- Study type: Observational
- Planned participants: 100
- From Aug 2025 to the primary completion date, Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone a liver transplant.
Other illness
- 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 with significant comorbid conditions that may interfere with the study outcomes, such as severe cardiovascular, renal, or pulmonary diseases.
Other
- Patients that do not meet inclusion criteria.
- Presence of cirrhosis or hepatic decompensation at the time of study enrollment.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.