CTIS2023-507007-60-00招募中1 期
CareCN: A phase I/II, open-label, study to evaluate the safety and efficacy of an intravenous injection of GNT0003 (Adeno-associated Viral Vector expressing the UGT1A1 transgene) in patients with severe Crigler-Najjar syndrome requiring phototherapy - GNT-012-CRIG
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Genethon
- 入组人数
- 17
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
- 0 至 65+（—）
- 性别
- All
入选标准
- •Patients with severe Crigler-Najjar syndrome requiring daily phototherapy (= 6h/day), Molecular confirmation of mutation in the UGT1A1 gene by DNA sequencing
排除标准
- •Fibrosis score = 3 (METAVIR) or 10 kPa, Patients who underwent liver transplantation
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