NCT02939820Approved For Marketing不适用
Expanded Access Protocol of Patisiran for Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR Amyloidosis) With Polyneuropathy
Alnylam Pharmaceuticals0 个研究点开始时间: 2016年10月20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
- 发起方
研究概览
简要总结
The purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).
详细描述
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the links provided in More Information.
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
- •Male or female greater than or equal to 18 years of age
- •Have a diagnosis of hATTR
- •Meet Karnofsky performance status and Polyneuropathy Disability (PND) score requirements
- •Have adequate complete blood counts, liver function tests and coagulation tests
排除标准
- •Participated in an interventional hATTR amyloidosis clinical trial involving RNA interference (RNAi) therapeutics within the last 12 months
- •Are currently eligible to participate in or currently enrolled in an ongoing interventional hATTR amyloidosis clinical trial
- •Have inadequate cardiac function
- •Known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
- •Have known serious comorbidities or considered unfit for the program by the investigator
- •Prior or planned liver or heart transplantation
研究者
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