NL-OMON56804撤回不适用
Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV) in Patients with Plakophilin 2 (PKP2)-associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) - Study of Patients with Arrhythmogenic Right Ventricular Cardiomyopathy
Tenaya Therapeutics Inc.0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 64（—）
入选标准
- •1. Ages 14 to 65 years, inclusive, at time of consent
- •2. Pathogenic or likely pathogenic PKP2 gene mutation
- •3. Diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC
- •4. Functioning ICD
排除标准
- •1. Currently receiving systemic immunosuppressive therapy, cytotoxic
- •chemotherapy, immunoglobulin therapy, or monoclonal antibody therapy
- •2. History of clinically significant liver disease, hepatitis B virus,
- •hepatitis C virus, human immunodeficiency virus, or tuberculosis infection
- •3. Previously dosed with any investigational or approved gene therapy product
- •at any time
- •4. Concurrent participation in another interventional clinical trial unless
- •approved by the Sponsor. Participation in a noninterventional study may be
- •allowed at the investigator*s discretion
- •5. History of cardiac transplant
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