EUCTR2013-003564-31-IT进行中（未招募）1 期
Multicentre, Retrospective Study to Assess Long-Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With - N/A
IVAR LTD0 个研究点目标入组 90 人开始时间: 2018年4月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients aged 1 year to 90 years of age
- •2. Physician-established diagnosis of Wilson disease based on a Ferenci score = 3
- •3. 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
- •4. Able/willing to provide written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Incomplete history of medication use for trientine from initial diagnosis to last follow-up
- •2. Unavailable outcome data for hepatic and neurological course of disease at all assessment time points
- •3. Patients with acute liver failure and fulminant hepatic disease with fatal outcome.
研究者
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