Resumen

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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 symptomatic PAH classified as WHO Functional Class II or III

Criterios de exclusión

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 a weight of \<35 kg
Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include 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 history of atrial septostomy (within 180 days prior to study start)
Has personal or family history of long QT syndrome
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

Intervenciones

biological

Sotatercept

SC administered every 3 weeks.

biological

Background PAH Therapy

Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists

Ubicaciones

Centro Medico Capital ( Site 0002)

La Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

Mar del Plata, Buenos Aires, Argentina

Instituto Medico Rio Cuarto ( Site 0010)

Río Cuarto, Córdoba Province, Argentina

Hospital Britanico de Buenos Aires ( Site 0004)

CABA, Argentina

Instituto de Cardiologia Juana F. Cabral ( Site 0008)

Corrientes, Argentina

Hospital Provincial Jose Maria Cullen ( Site 0005)

Santa Fe, Argentina

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