NL-OMON45944已完成不适用
A comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the dietary management of hepatic glycogen storage diseases (GSD) - Glycosade® vs. UCCS in Hepatic GSD (GLYDE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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
- 2 至 99（—）
入选标准
- •See the study protocol, §6.1:;Patients with GSD I, III, VI or IX under the care of a metabolic centre meeting the following inclusion criteria:
- •* Diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). For those whom mutation analysis is not completed this will be assessed during the study.
- •* Adults and children aged 2 years or older.
- •* Established on UCCS for at least 6 months to full dietary requirements as defined by local clinical practice.
- •* Freely given informed written consent from participant or parent/caregiver.
排除标准
- •See the study protocol, §6.2;* Evidence of any other medical condition which in the opinion of the Investigator makes it undesirable for the subject to participate in the trial or which would jeopardise compliance with the protocol.;* Women pregnant / breastfeeding at the start of the study or planning to become pregnant during its duration. ;Note: Women who become pregnant unexpectedly during this study can continue on the study product if they wish.
研究者
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