Multicentre, Retrospective and Prospective Study to Assess Long Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With d-Penicillamine

nivar B.V.0 个研究点目标入组 90 人开始时间: 2013年10月22日最近更新: 2018年8月27日

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•- Patients aged 1 year to 90 years of age at initiation of treatment with trientine.
•- Physician established diagnosis of Wilson disease based on a Ferenci score > 3 at the date of diagnosis.
•- Documented treatment with d-Penicillamine, withdrawal of treatment with d- Penicillamine, followed by treatment with trientine for at least 6 months at date of informed consent.
•- Able/willing to provide written informed consent.
•For enrolment in the prospective part:
•- Enrolment in the retrospective part of the study.
•- On-going treatment with trientine.
•- Negative pregnancy test.
•- Able/willing to provide written informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•- Incomplete history of medication use for trientine from initial diagnosis to latest follow up.
•- Unavailable outcome data for hepatic and neurological course of disease at initiation of treatment with trientine and at least 1 time point post-initiation of treatment with trientine.
•For enrolment in the prospective part:
•- Hypersensitivity to trientine
•- Severe anaemia.

发起方

nivar B.V.