Monitoring the Response of Combination Ursodiol and Seladelpar Treatment in Primary Biliary Cholangitis Using Invasive Markers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- ALP and bilirubin levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
ALP and bilirubin levels
时间窗: through study completion, up to 18 months
Pruritus severity using the pruritus numeric rating scale
次要结局
未报告次要终点