A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

Официальное название

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.

Обзор

The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.

Вмешательства

• Биопрепарат Sotatercept
  Sotatercept subcutaneous injection every 3 weeks

Первичные конечные точки

• Number of Participants With One or More Adverse Events [Срок оценки: Up to approximately 24 weeks]
• Number of Participants Who Discontinue Study Intervention Due to an Adverse Event [Срок оценки: Up to approximately 24 weeks]
• Laboratory Parameter (Hematology): Concentration of Hemoglobin [Срок оценки: Up to approximately 24 weeks]
• Laboratory Parameter (Hematology): Hematocrit [Срок оценки: Up to approximately 24 weeks]
• Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count [Срок оценки: Up to approximately 24 weeks]
• Laboratory Parameter (Hematology): Reticulocyte Count [Срок оценки: Up to approximately 24 weeks]
• Laboratory Parameter (Hematology): Platelet Count [Срок оценки: Up to approximately 24 weeks]
• Blood Pressure (BP) [Срок оценки: Up to approximately 24 weeks]
• Number of Participants with Detectable Anti-Drug Antibodies (ADAs) [Срок оценки: Up to approximately 24 weeks]
• Number of Participants with Detectable Neutralizing Antibodies to Sotatercept [Срок оценки: Up to approximately 24 weeks]

Вторичные конечные точки (12)

• Mean Change from Baseline in 6-Minute Walk Distance (6MWD) [Срок оценки: Baseline and Week 24]
• Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) [Срок оценки: Baseline and Week 24]
• Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC) [Срок оценки: Baseline and Week 24]
• Number of Participants With One or More Adverse Events [Срок оценки: From Week 24 up to approximately 58 months]
• Number of Participants Who Discontinue Study Intervention Due to an Adverse Event [Срок оценки: From Week 24 up to approximately 58 months]
• Laboratory Parameter (Hematology): Concentration of Hemoglobin [Срок оценки: From Week 24 up to approximately 58 months]
• Laboratory Parameter (Hematology): Hematocrit [Срок оценки: From Week 24 up to approximately 58 months]
• Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count [Срок оценки: From Week 24 up to approximately 58 months]
• Laboratory Parameter (Hematology): Reticulocyte Count [Срок оценки: From Week 24 up to approximately 58 months]
• Laboratory Parameter (Hematology): Platelet Count [Срок оценки: From Week 24 up to approximately 58 months]
• Blood Pressure (BP) [Срок оценки: From Week 24 up to approximately 58 months]
• Number of Participants with Detectable ADAs [Срок оценки: From Week 24 up to approximately 58 months]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization
• Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt
• Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV
• Has been receiving stable standard-of-care background therapy for PAH for at least 90 days
• Is Japanese

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• History of left-sided heart disease
• Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
• History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days
• Has unrepaired or residual cardiac shunt with Qp/Qs >1.5
• Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and/or venous involvement
• PAH associated with portal hypertension
• Known visceral arteriovenous malformations
• History of full or partial pneumonectomy
• Untreated more than mild obstructive sleep apnea
• History of known pericardial constriction
• Family history of sudden cardiac death or long QT syndrome
• History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months
• Prior treatment with sotatercept or luspatercept

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07646860 · 7962-032 · MK-7962-032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗