临床试验/NCT02932449

NCT02932449已完成不适用

A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

Target PharmaSolutions, Inc.39 个研究点分布在 1 个国家目标入组 711 人开始时间: 2016年10月1日最近更新: 2026年2月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Target PharmaSolutions, Inc.
入组人数: 711
试验地点: 39
主要终点: Examine biochemical response and its association with long term outcomes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

Target PharmaSolutions, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (39)

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