EUCTR2009-012978-12-NO进行中（未招募）1 期
A Phase IV, prospective, open-label, uncontrolled, single-centre cohort trial to be conducted in Norway to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® 20 mg/kg/day for 7 days. - Response to Kuvan® in subjects with PKU from a single centre in Norway
Merck Serono, an affiliate of E. Merck AB0 个研究点开始时间: 2009年6月2日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects will be included if they meet the following requirements:
- •aged between =16 years and 65 years at the screening visit
- •diagnosed with PKU (classic PKU, mild PKU or mild HPA)
- •previously untreated with sapropterin dihydrochloride
- •baseline blood PHE measurement =400 µmol/L
- •agreed to comply with study procedures
- •provided written informed consent.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria are:
- •documented BH4 deficiency
- •pregnant, planning pregnancy or breastfeeding.
研究者
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