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临床试验/NCT03400098
NCT03400098Approved For Marketing不适用

Expanded Access Program for Inotersen (ISIS 420915) in Patients With Hereditary Transthyretin Amyloidosis (hATTR)

Ionis Pharmaceuticals, Inc.0 个研究点开始时间: 2018年1月17日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
Approved For Marketing

研究概览

简要总结

The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).

详细描述

The Program is intended to provided expanded access to Inotersen for eligible patients with hATTR who have limited or no available treatment options.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female at least 18 years of age with a diagnosis of hATTR
  • Symptoms consistent with polyneuropathy
  • Meet Polyneuropathy Disability (PND) Stage I-III requirements

排除标准

  • Known Primary Amyloidosis, Leptomeningeal Amyloidosis or Monoclonal Gammopathy of Undetermined Significance or Multiple Myeloma
  • Have inadequate cardiac function
  • Have low platelet counts
  • Have inadequate renal function

研究者

申办方类型
Industry
责任方
Sponsor

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