2024-512278-92-00招募中2 期
A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or 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
- 81
- 试验地点
- 37
- 主要终点
- Steady-state average serum concentrations of sotatercept (Cavg)
研究概览
简要总结
- To evaluate the steady-state systemic exposure of sotatercept using weight-banded dosing relative to the exposure using weight-based dosing following multiple (maintenance doses) dose administration at steady state.
- To evaluate the safety and tolerability of sotatercept over 24 weeks of treatment
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 documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- •Has systemic PAH classified as WHO Functional Class II or III
排除标准
- •Has weight of <35kg
- •Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
- •Has a cerebrovascular accident (within 3 months prior to study start)
- •Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
- •Has untreated more than mild obstructive sleep apnea
- •Has known malignancy that is progressing or has required active treatment within the past 5 years
- •Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
- •Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device
- •Has diagnosis of Pulmonary Hypertension WHO Groups 2, 3, 4, or 5
- •Has a diagnosis of the following PAH Group 1 subtypes: Human Immunodeficiency Virus (HIV)-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 also includes: schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
- •Has uncontrolled systemic hypertension
- •Has a history of pneumonectomy
- •Has a history of known pericardial constriction
- •Has a history of restrictive cardiomyopathy
- •Has a history of atrial septostomy (within 180 days prior to study start)
- •Has personal or family history of long QT syndrome
结局指标
主要结局
Steady-state average serum concentrations of sotatercept (Cavg)
Steady-state average serum concentrations of sotatercept (Cavg)
Number of participants who experience one or more adverse events (AEs)
Number of participants who experience 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
- Initial dose average serum concentrations of sotatercept (Cavg)
研究者
Michela Brambatti
Scientific
Merck Sharp & Dohme LLC
研究点 (37)
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