NCT02932449已完成不适用
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 39
- 主要终点
- Examine biochemical response and its association with long term outcomes
研究概览
简要总结
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult patients (age 18 or older) being treated or managed for PBC
排除标准
- •Inability to provide written informed consent
- •Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC
结局指标
主要结局
Examine biochemical response and its association with long term outcomes
时间窗: up to 5 years
Evaluate PBC treatment regimens being used in clinical practice
时间窗: up to 5 years
Examine populations underrepresented in phase III clinical trials
时间窗: up to 5 years
Estimate adverse event frequency and severity and describe management practices
时间窗: up to 5 years
次要结局
未报告次要终点
研究者
研究点 (39)
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