A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
7 de septiembre de 2026 actualizado por: Merck Sharp & Dohme LLC
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.
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
6
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Toll Free Number
- Número de teléfono: 1-888-577-8839
- Correo electrónico: Trialsites@merck.com
Ubicaciones de estudio
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Osaka
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Izumi, Osaka, Japón, 594-1101
- Reclutamiento
- Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)
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Contacto:
- Study Coordinator
- Número de teléfono: +81-725-56-1260
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Suita, Osaka, Japón, 565-0871
- Reclutamiento
- The University of Osaka Hospital ( Site 3201)
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Contacto:
- Study Coordinator
- Número de teléfono: +81-6-6879-5111
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Tokyo
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Setagaya City, Tokyo, Japón, 157-8535
- Reclutamiento
- National Center for Child Health and Development ( Site 3202)
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Contacto:
- Study Coordinator
- Número de teléfono: +81-3-3416-0181
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
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
Exclusion Criteria:
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sotatercept
Participants receive sotatercept by subcutaneous injection every 3 weeks (Q3W) for up to approximately 24 weeks while continuing standard-of-care background therapy for PAH.
Participants start at a dose of 0.3 mg/kg Q3W, and may titrate up to the target dose of 0.7 mg/kg SC injection Q3W starting at Week 6 based on protocol-defined dose-escalation guidance.
After Week 24, participants who meet certain requirements may choose to continue receiving sotatercept for up to 58 months.
|
Sotatercept subcutaneous injection every 3 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With One or More Adverse Events
Periodo de tiempo: Up to approximately 24 weeks
|
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Up to approximately 24 weeks
|
|
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Periodo de tiempo: Up to approximately 24 weeks
|
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
Up to approximately 24 weeks
|
|
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Periodo de tiempo: Up to approximately 24 weeks
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The concentration of hemoglobin will be presented.
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Up to approximately 24 weeks
|
|
Laboratory Parameter (Hematology): Hematocrit
Periodo de tiempo: Up to approximately 24 weeks
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The hematocrit will be presented.
|
Up to approximately 24 weeks
|
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Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Periodo de tiempo: Up to approximately 24 weeks
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The RBC count will be presented.
|
Up to approximately 24 weeks
|
|
Laboratory Parameter (Hematology): Reticulocyte Count
Periodo de tiempo: Up to approximately 24 weeks
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The reticulocyte count will be presented.
|
Up to approximately 24 weeks
|
|
Laboratory Parameter (Hematology): Platelet Count
Periodo de tiempo: Up to approximately 24 weeks
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The platelet count will be presented.
|
Up to approximately 24 weeks
|
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Blood Pressure (BP)
Periodo de tiempo: Up to approximately 24 weeks
|
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
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Up to approximately 24 weeks
|
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Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Periodo de tiempo: Up to approximately 24 weeks
|
Blood samples will be collected to assess antidrug antibodies to sotatercept.
The number of participants with detectable ADAs at any time during the study will be presented.
|
Up to approximately 24 weeks
|
|
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Periodo de tiempo: Up to approximately 24 weeks
|
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as antidrug antibody-positive.
The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
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Up to approximately 24 weeks
|
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Serum Trough Concentration (Ctrough) of Sotatercept
Periodo de tiempo: At designated time points and up to approximately 24 weeks
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Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept.
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At designated time points and up to approximately 24 weeks
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Change From Baseline in Pulmonary Vascular Resistance Index (PVRI)
Periodo de tiempo: Baseline and Week 24
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The change from baseline in PVRI will be presented.
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Baseline and Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio medio desde el inicio en el péptido natriurético tipo B de la prohormona N-terminal (NT-proBNP)
Periodo de tiempo: Línea de base y semana 24
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Se informará el cambio desde el inicio en los niveles plasmáticos de NT-proBNP.
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Línea de base y semana 24
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Porcentaje de participantes que mejoraron o mantuvieron su clase funcional de la Organización Mundial de la Salud (OMS FC)
Periodo de tiempo: Línea de base y semana 24
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La gravedad de los síntomas de HAP de una persona se clasificará mediante el sistema de FC de la OMS.
La clasificación funcional de la OMS para la HAP oscila entre Clase I (sin limitación de la actividad física, sin disnea con la actividad normal), Clase II (ligera limitación de la actividad física), Clase III (marcada limitación de la actividad física) y Clase IV (no puede realizar una actividad física). actividad sin síntomas, disnea de reposo).
El cambio con respecto al valor inicial en la FC de la OMS se clasificará en "Mejorado", "Sin cambios" y "Emperado".
Mejora = reducción de FC, empeorado = aumento de FC y sin cambio = sin cambio de FC.
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Línea de base y semana 24
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Mean Change from Baseline in 6-Minute Walk Distance (6MWD)
Periodo de tiempo: Baseline and Week 24
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6MWD will be assessed using the 6-minute walk test (6MWT).
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Baseline and Week 24
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Number of Participants With One or More Adverse Events
Periodo de tiempo: From Week 24 up to approximately 58 months
|
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
From Week 24 up to approximately 58 months
|
|
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Periodo de tiempo: From Week 24 up to approximately 58 months
|
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
From Week 24 up to approximately 58 months
|
|
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The concentration of hemoglobin will be presented.
|
From Week 24 up to approximately 58 months
|
|
Laboratory Parameter (Hematology): Hematocrit
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The hematocrit will be presented.
|
From Week 24 up to approximately 58 months
|
|
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The RBC count will be presented.
|
From Week 24 up to approximately 58 months
|
|
Laboratory Parameter (Hematology): Reticulocyte Count
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The reticulocyte count will be presented.
|
From Week 24 up to approximately 58 months
|
|
Laboratory Parameter (Hematology): Platelet Count
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator.
The platelet count will be presented.
|
From Week 24 up to approximately 58 months
|
|
Blood Pressure (BP)
Periodo de tiempo: From Week 24 up to approximately 58 months
|
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
|
From Week 24 up to approximately 58 months
|
|
Number of Participants with Detectable ADAs
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Blood samples will be collected to assess antidrug antibodies to sotatercept.
The number of participants with detectable ADAs at any time during the study will be presented.
|
From Week 24 up to approximately 58 months
|
|
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Periodo de tiempo: From Week 24 up to approximately 58 months
|
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as ADA-positive.
The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
|
From Week 24 up to approximately 58 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
25 de septiembre de 2026
Finalización primaria (Estimado)
24 de mayo de 2029
Finalización del estudio (Estimado)
16 de mayo de 2031
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 7962-032
- MK-7962-032 (Otro identificador: MSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .