A 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 - Sotatercept in Children with PAH on SoC

Merck Sharp & Dohme LLC0 sites42 target enrollmentNovember 22, 2022

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female participants \=1 to \<18 years of age at the time of providing documented informed consent/assent
•2\. Documented, historic diagnostic RHC any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes (for participants with a history of cardiac intervention for shunt closure, the RHC confirmation must have been performed more than 6 months after the cardiac intervention):
•\- Heritable PAH
•\- Drug/toxin\-induced PAH
•\- PAH associated with CTD
•\- PAH\-CHD with shunt closure \>6 months before Screening and subsequently confirmed by RHC before Screening
•\- PAH with coincidental shunt
•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:

•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 developemental abnormalities of the lung, thorax, and/or diaphragm
•3\. History of Eisenmenger syndrome, Potts shunt, or arterial septostomy
•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