临床试验/DRKS00028305

DRKS00028305招募中不适用

Prospective, descriptive, non-interventional, German multicenter study to evaluate the quality of life of Wilson disease patients after switching from D-penicillamine to trientine tetrahydrochloride and to assess clinical and patient reported outcomes - PACUS

Orphalan GmbH0 个研究点目标入组 60 人开始时间: 2022年3月8日最近更新: 2024年8月19日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Orphalan GmbH
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: 18 Years 至 one（—）
性别: All

入选标准

•Patients with provided written informed consent form (ICF) and a data protection consent.
•Adult patients (= 18 years) of any gender diagnosed with Wilson disease (ICD-10 E83.0).
•Patients previously treated with DPA with intolerance of the medication, which leads to a medication switch to Cuprior®. Patients should require a therapy switch from current DPA to Cuprior® treatment based on physician assessment and approval and before enrollment in the study.

排除标准

•Patients without filed prescription of Cuprior® or existing evidence of decision to switch.
•Patient without recorded manifestation of DPA intolerance.
•Patients with anticipated impossibility to be followed up for any reasons.
•Patients switched to other Wilson disease therapies (trientine dihydrochloride, zinc salts).

研究者

发起方

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