2024-518687-12-00招募中2 期
An Open-label Extension Study to Evaluate the Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 28
- 主要终点
- Number of participants with one or more adverse events (AEs)
研究概览
简要总结
- To evaluate the long-term safety and tolerability of sotatercept using weight-banded dosing
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)
- •Has not started treatment with commercially available sotatercept
排除标准
- •Has prior exposure to luspatercept and/or is planning to begin treatment with luspatercept while enrolled in the study
结局指标
主要结局
Number of participants with one or more adverse events (AEs)
Number of participants with one or more adverse events (AEs)
Number of participants who discontinue study intervention due to an AE
Number of participants who discontinue study intervention due to an AE
次要结局
未报告次要终点
研究者
Michela Brambatti
Scientific
Merck Sharp & Dohme LLC
研究点 (28)
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