An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 21
- 主要终点
- Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
研究概览
简要总结
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Participants must have biopsy-confirmed IgA Nephropathy
排除标准
- •Any secondary IgAN
- •Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
研究组 & 干预措施
BHV-1400
干预措施: BHV-1400 (Drug)
结局指标
主要结局
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
时间窗: Up to 1 year
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths
Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities
时间窗: Up to 1 year
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
次要结局
未报告次要终点