NL-OMON53701尚未招募2 期
Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care - MK7962-008
Merck Sharp & Dohme (MSD)0 个研究点目标入组 1 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
入选标准
- •The main inclusion criteria are listed here. For a complete list of inclusion
- •please refer to the research protocol.
- •1. Male or female participants >=1 to <18 years of age at the time of providing
- •documented informed consent/assent:
- •Cohort 1: Age >=12 to <18 years of age
- •Cohort 2: Age >=6 to <12 years of age
- •Cohort 3: Age >=2 to <6 years of age
- •Cohort 4: Age >=1 to <2 years of age
- •2. Documented, historic diagnostic RHC any time before Screening confirming the
- •diagnosis of PAH WHO Group 1.
- •3. For the above-mentioned historical RHC, diagnostic criteria will be mean
- •pulmonary artery pressure >=20 mmHg at rest, pulmonary capillary wedge pressure
- •or left ventricular end-diastolic pressure <=15 mmHg, and PVR indexed to body
- •surface area, >= 3.0 WU.m2
- •4. PAH classified as WHO FC I or symptomatic PAH classified as WHO FC II to IV
- •5. Participants must be on a stable dose(s) of background PAH therapy
- •6. Arterial BP at Screening within normal range for the age, gender, and height
- •percentiles
- •7. Left ventricular ejection fraction >=50% on the ECHO at Screening
排除标准
- •The main exclusion criteria are listed here. For a complete list of exclusion
- •please refer to the research
- •1. History of left-sided heart disease, including valvular disease (eg,
- •moderate or greater mitral or aortic regurgitation or stenosis), left
- •ventricular outflow tract obstruction, and/or left heart failure (eg,
- •restrictive or dilated cardiomyopathy)
- •2 Severe (as based on the opinion of the investigator) congenital or
- •developmental abnormalities of the lung, thorax, and/or diaphragm
- •3. History of Eisenmenger syndrome, Potts shunt, atrial septostomy within 180
- •days prior to the screening visit, or atrial septostomy with Eisenmenger
- •4. Unrepaired or residual cardiac shunt with Qp/Qs >1.5
- •5. Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary
- •hemangiomatosis, or overt signs of capillary and/or venous involvement
- •6. PAH associated with portal hypertension
- •7. Known visceral (lung, liver, or brain) arteriovenous malformation(s)
- •8. History of full or partial pneumonectomy
- •9. Untreated more than mild obstructive sleep apnea
- •10. History of known pericardial constriction
- •11. Family history of sudden cardiac death or long QT syndrome
- •12. Any current or prior history of symptomatic coronary disease (myocardial
- •infarction, percutaneous coronary intervention, coronary artery bypass graft
- •surgery, or cardiac anginal chest pain) within 6 months before Screening
- •13. Cerebrovascular accident within 3 months before Screening
- •14. Prior exposure to sotatercept or luspatercept or has had an allergic
- •reaction to any of their excipients
- •15. Currently enrolled in or has completed a study with any other
- •investigational products (small molecule drugs or biologics) within 30 days or
- •5 half-lives of that investigational product (whichever is longer) before
研究者
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