Sponsor-Initiated Expanded Access Program (SYN023-EAP-001) for SYN023 (Zamerovimab + Mazorelvimab): Compassionate Use of SYN023 in Patients With Confirmed or Suspected Life-Threatening Rabies Infection
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
This sponsor-initiated Expanded Access Program provides compassionate-use SYN023, a dual monoclonal antibody cocktail (zamerovimab + mazorelvimab) targeting rabies virus glycoprotein, for US patients with confirmed or suspected life-threatening rabies lacking adequate alternative therapies.
详细描述
The goal of this expanded access program is to learn about the safety and clinical outcomes of SYN023 in patients with confirmed or suspected rabies infection who receive SYN023 as compassionate-use treatment for life-threatening rabies. The main question it aims to answer is:
Does SYN023 provide clinical benefit and demonstrate manageable safety profiles in patients with confirmed or suspected life-threatening rabies when administered alongside standard rabies care? Participants receiving SYN023 as part of their emergency compassionate-use care for rabies will have clinical safety, serologic and disease course data collected throughout their treatment course to support continuous pharmacovigilance and future SYN023 clinical development.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ineligible for or lack access to other investigational or approved therapies
- •Must have no available alternative curative treatment options
排除标准
- •No standardized universal exclusion criteria are predefined for this Expanded Access Program.
- •- Clinical contraindications identified on an individual basis by the treating critical care clinician