JPRN-jRCT2033230266招募中3 期
Phase 3, Open-label, Single-dose, Multicenter Study Investigating Efficacy and Safety of a Serotype 5 Adeno-associated Viral Vector Containing the Padua Variant of a Codon-optimized Human Factor IX Gene (AAV5-hFIXco-Padua, CSL222) Administered to Japanese Adult Male Subjects with Severe or Moderately Severe Hemophilia B
Akama Hideto0 个研究点目标入组 4 人开始时间: 2023年7月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •Males of Japanese origin, Age >= 18 years
- •Subject with congenital hemophilia B with known severe or moderately severe FIX deficiency (<= 2% of normal circulating FIX) for which the subject is on continuous routine FIX prophylaxis
- •> 150 previous exposure days of FIX replacement therapy
排除标准
- •History of FIX inhibitors
- •Positive human immunodeficiency virus serological test
- •Hepatitis B or C infection
- •Known coagulation disorder other than hemophilia B
研究者
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