Study Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Time to the first occurrence of the composite endpoint of all-cause death, liver transplant, or hepatic decompensation.
研究概览
简要总结
This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid (OCA) to patients with PBC who failed UDCA treatment and were not treated with second-line therapy. The study is designed to evaluate the effectiveness of OCA. All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria will be considered for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Definite or probable PBC diagnosis
- •UDCA failure
- •Age ≥18 years at the index date
- •Evaluable data for at least 12 months before the index date (inclusive)
排除标准
- •History or presence of other concomitant liver diseases
- •Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
- •History of liver transplant
- •Evidence of OCA, fenofibrate, or bezafibrate use
- •History or presence of hepatic decompensating events
- •Participation in a clinical trial for a PBC medication
研究组 & 干预措施
OCA Treatment Group
PBC patients with a history of UDCA failure who initiated OCA in the study window (01 Jun 2015 to 31 Dec 2021)
干预措施: Obeticholic Acid 10 MG (Drug)
OCA Treatment Group
PBC patients with a history of UDCA failure who initiated OCA in the study window (01 Jun 2015 to 31 Dec 2021)
干预措施: Obeticholic Acid 5 MG (Drug)
结局指标
主要结局
Time to the first occurrence of the composite endpoint of all-cause death, liver transplant, or hepatic decompensation.
时间窗: Time from index date to first occurrence of the composite endpoint events, assessed up to 62 months.
次要结局
未报告次要终点