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临床试验/NCT02300753
NCT02300753No Longer Available不适用

Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]

Edison Pharmaceuticals Inc1 个研究点 分布在 1 个国家开始时间: 2014年11月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available
试验地点
1

研究概览

简要总结

Expanded access Protocol to treat LHON subjects with EPI743

详细描述

Emergency use administration of EPI-743 to subjects with LHON. This Protocol was originally developed to treat a single subject but was expanded to treat several at a single institution.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
8 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Emergency treatment for subjects with LHON who are actively losing site in one eye

排除标准

  • Allergy to EPI-743 or sesame oil
  • Clinical history of bleeding or abnormal PT/PTT
  • Hepatic insufficiency with LFTs greater than 2-times normal
  • Renal insufficiency requiring dialysis
  • Fat malabsorption syndromes
  • Any other concurrent inborn erros of metabolism
  • Severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis
  • Anemia with a HCT <25

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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