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临床试验/EUCTR2017-004153-17-DK
EUCTR2017-004153-17-DK进行中(未招募)1 期

Evaluation of the effect of Triheptanoin on fatty acid oxidation and exercise tolerance in patients with debrancher deficiency, glycogenin-1 deficiency and phosphofructokinase deficiency at rest and during exercise. A randomized, double-blind, placebo-controlled, cross-over study. - Triheptanoin in Glycogenoses

Copenhagen Neuromuscular Center0 个研究点目标入组 20 人开始时间: 2018年3月26日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

  • - Male/Female Age > 15 years
  • - Genetically and/or biochemically verified diagnosis of GSD III, GSD VII or GSD XV
  • - Capacity to consent
  • - For women in fertile age on contraceptive treatment with: Birth control
  • pills, coil, ring, transdermal hormone patch injection of gestagen or
  • subdermal implant.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 4
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 14
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • - Significant cardiac or pulmonary disease
  • - Pregnancy (confirmed by urine stix or plasma-HCG) or breastfeeding.
  • - Inability to perform cycling exercise
  • - Any other significant disorder that may confound the interpretation of
  • the findings

研究者

发起方
Copenhagen Neuromuscular Center

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