EUCTR2014-001703-41-AT进行中（未招募）1 期
A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older with an Extension Phase of 36 Months
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •- Willing and able to give informed consent for participation in the study.
- •- Male or female patients, aged 18 years or older as of signing the ICF.
- •- Able to understand and willing to comply with study procedures, restrictions and requirements, as judged by the Investigator.
- •- Newly established diagnosis of Wilson Disease by Leipzig-Score = 4 (Ferenci et al 2003) documented by testing as outlined in 2012 EASL WD Clinical Practice Guidelines.
- •- NCC levels above or within the normal reference range (0,8- 2.3 µM).
- •- Willing to undergo 48 hour washout from current Wilson Disease treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •- Treatment for greater than 24 months for Wilson Disease with chelation therapy (i.e. penicillamine, trientine hydrochloride) or zinc therapy.
- •- Decompensated hepatic cirrhosis.
- •- Model for End-Stage Liver Disease (MELD) score > 11.
- •- Modified Nazer score > 6 (Dhawan et al., 2005).
- •- GI bleed within past 6 months.
- •- ALT > 5x upper limit of normal (ULN).
- •- Hepatic fibrosis on either liver biopsy or fibroscan in subjects with ALT or AST > 2x upper limit of normal (ULN).
- •- Marked neurological disease requiring either nasogastric (NG) feeding or intensive in-patient medical care.
- •- Severe anaemia with a haemoglobin < 9 g/dL.
研究者
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