Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema (HAE)

Ionis Pharmaceuticals, Inc.0 个研究点开始时间: 2024年5月16日最近更新: 2026年9月4日

适应症

试验速览

阶段: 不适用
状态: Approved For Marketing
发起方: Ionis Pharmaceuticals, Inc.

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.

详细描述

The Expanded Access Program (EAP) is intended to provide pre-approval access to donidalorsen for eligible patients with HAE who complete the ISIS 721744-CS3 clinical trial.

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: 否

入选标准

•Patients in the ISIS 721744-CS3 (Open-Label Extension [OLE] Study) who have completed 205 weeks of treatment.
•Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity.

排除标准

•Any patient who is pregnant or plans to become pregnant.
•Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.

研究者

发起方

Ionis Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

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