NL-OMON48912已完成不适用
An open-label, explorative, post launch, multicenter, multi-country intervention study of PKU Synergy (an amino-acid mixture) to evaluate change in nutrient intake in PKU subjects with an increased Phe-tolerance/intake. - ESSENTIA
utricia Research0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •1. PKU subjects identified by newborn screening and started low-Phe diet before
- •3 months of age.
- •2. PKU subjects with an increased Phe-tolerance/intake due to: mild PKU
- •phenotype or BH4 treatment.
- •3. If treated with BH4, PKU subjects should be on a stable BH4 treatment for at
- •least 26 consecutive weeks up to start test product intake.
- •4. Age*12 years.
- •5. If subjects (irrespective whether BH4 users or mild PKU) use amino-acid
- •mixture(s; AAM), then a maximum of 25 Protein Equivalents (PE) derived from the
- •AAM per day applies and usage on a daily basis for at least 26 consecutive
- •weeks up to Visit 1
- •6. If subjects (irrespective whether BH4 users or mild PKU) use AAMs they
- •should be capable and willing to substitute their current AAM(s; maximum of 25
- •PE per day) with one portion of the test product per day
- •7. If subjects (irrespective whether BH4 users or mild PKU) use omega-3,
- •antioxidant, and/or vitamin supplements, to stop usage of the supplements and
- •be able and willing to substitute with the test product
- •8. Willing and able to comply with study procedures, 9. Willing and able to
- •provide informed consent (and assent in case of minors if required by local
- •law/regulations).
- •10. For women of childbearing potential: not to have the intention to become
- •pregnant during the study.
排除标准
- •1. For women: Currently pregnant or lactating.
- •2. Current or prior use of the test product within six weeks prior to entry
- •into the study.
- •3. Concurrent conditions (including renal failure and severe hepatic failure)
- •and medication that could interfere with participation, outcome parameters or
- •safety (as determined by Investigator).
- •4. Psychotropic medication (i.e. medication affecting the nervous system) and
- •inotropic medication.
- •5. Any condition creating high risk of poor compliance with study.
- •6. Participation in any other studies involving investigational or marketed
- •products concomitantly or within six weeks prior to entry into the study.
- •Except for studies related to Kuvan® (synthetic tetrahydrobiopterin (BH4))
- •without diagnostic, therapeutic or experimental intervention.
研究者
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