2026-526359-75-00招募中4 期
A Rollover Study to Follow the Long-term Durability of Response to UGN-103 in Participants From Study BL013
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Duration of response (DOR)
研究概览
简要总结
Collect long-term durability of response data from participants with an ongoing complete response to UGN-103 at the end of Study BL013
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has provided written informed consent for the rollover study.
- •Participant completed Study BL013 with an ongoing CR
排除标准
- •Participant has not provided written informed consent for the rollover protocol.
- •2.Participant did not complete Study BL013 with an ongoing CR
研究组 & 干预措施
UGN-103 (Mitomycin)
Test
干预措施: UGN-103 (Mitomycin) (Drug)
结局指标
主要结局
Duration of response (DOR)
Duration of response (DOR)
次要结局
未报告次要终点
研究者
Sebastian Mirkin
Scientific
Urogen Pharma Ltd.
研究点 (12)
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