NCT07632898尚未招募3 期
Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 484
研究概览
简要总结
This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent.
- •Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.
排除标准
- •Any of the following clinical laboratory values at screening:
- •ALT or AST levels >3× the ULN
- •Bilirubin levels >2× the ULN
- •ANC <1.2 ×10^9 cells/L, hemoglobin <9 g/dL, hematocrit <30%, or platelets <75 × 10^9 cells/L
- •Absolute eGFR <30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021)
- •Currently lactating, pregnant or planning on becoming pregnant during the study.
- •Receiving treatment with sotatercept.
研究者
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