jRCT2031250734招募中不适用
A randomized, double-blind, placebo-controlled, parallel group, Phase 3 study, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation
未提供0 个研究点目标入组 180 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant >=1 year post bilateral lung transplantation at the time of screening.
- •Participants presenting with CLAD Stage 1 or 2: Forced expiratory volume in 1 second (FEV1) from >50% to 80% of post-transplant baseline at screening and at randomization.
- •Participants who have received at least 8 weeks of azithromycin (>=250 mg/day, at least 3 times a week) prior to randomization.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •FEV1 <=50% of the post-transplant baseline value (CLAD 3 and 4).
- •Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia.
研究者
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