Design and E E ndpoints for C C linical T T rials in P P rimary S S clerosing C C holangitis

Ponsioen Cyriel Y.; Lindor Keith D.; Mehta Ruby; Dimick‐Santos Lara

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Design and E E ndpoints for C C linical T T rials in P P rimary S S clerosing C C holangitis

机译：用于初级硬化性胆管炎的C c划边T T rials的设计和e Ndpoints

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Primary sclerosing cholangitis (PSC) is a rare and chronic liver disease for which there is no effective therapy. Interest has grown in developing treatments for this condition, with several agents proposed as potential therapies. However, there is a lack of clarity about how to measure clinical benefit in trials involving patients with this complex and rare disease. This article reviews regulatory information, the available literature on natural history, as well as potential candidate clinical and surrogate endpoints for PSC. (H epatology 2018; 00:000‐000).

机译：原发性硬化胆管炎（PSC）是一种罕见的慢性肝病，没有有效的治疗。利息已经在发育这种情况下的治疗中，提出了几种试剂作为潜在疗法。然而，关于如何测量涉及这种复杂疾病和罕见疾病的患者的试验中的临床益处缺乏清楚起见。本文审查了法规信息，可用的自然历史上的文献，以及PSC的潜在候选临床和代理终点。（2018普遍存在2018; 00：000-000）。

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来源
《Hepatology: Official Journal of the American Association for the Study of Liver Diseases》 |2018年第3期|共15页
作者
Ponsioen Cyriel Y.; Lindor Keith D.; Mehta Ruby; Dimick‐Santos Lara;
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作者单位

Department of Gastroenterology &

HepatologyAcademic Medical CenterAmsterdam The Netherlands;

College of Health SolutionsArizona State UniversityPhoenix AZ;

Division of Gastroenterology and Inborn Errors ProductsUnited States Food and Drug;

Division of Gastroenterology and Inborn Errors ProductsUnited States Food and Drug;

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原文格式 PDF
正文语种 eng
中图分类消化系及腹部疾病;
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Design and E E ndpoints for C C linical T T rials in P P rimary S S clerosing C C holangitis

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