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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07600723
A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037)
A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India
Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. This causes high blood pressure in the lungs and can overwork the heart. PAH can make it hard to breathe and be active.
Researchers want to learn if sotatercept, the study medicine, can be given with standard treatment to help treat PAH. The standard treatment (the usual treatment) for PAH includes one or multiple medicines. However, these may not fully work or treat the symptoms of PAH in some people.
The goal of this study is to learn about the safety and tolerability of sotatercept when it is given with standard treatment to people in India.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Toll Free Number
- Número de telefone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has documented historical diagnostic right heart catheterization (RHC), with the diagnosis of pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH), in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, and PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- Has been on stable doses of PAH background therapies and diuretics (if applicable)
- Has symptomatic PAH classified as World Health Organization (WHO) Functional Classification (FC) II or III
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of Groups 2, 3, 4, or 5 PH
- Has a diagnosis of the following PAH (Group 1 PH) subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, PAH diagnosed with pulmonary veno occlusive disease (PVOD) or pulmonary capillary hemangiomatosis (PCH)
- Has uncontrolled systemic hypertension
- Has a history of full or partial pneumonectomy
- Has untreated more than mild obstructive sleep apnea
- Has known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C
- Has a history of restrictive, constrictive, or congestive cardiomyopathy
- Has significant mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis, and more than mild aortic valve stenosis
- Has known malignancy that is progressing or has required active treatment within the past 5 years
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Sotatercept
Participants receive a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy.
|
Administered as SC injection
Outros nomes:
Background PAH therapy refers to approved PAH-specific medications and may consist of a single, double, or triple combination of therapy with Endothelin Receptor Antagonists (ERAs), Phosphodiesterase Type 5 Inhibitors (PDE5), soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants who experience an adverse event (AE)
Prazo: Up to approximately 37 weeks
|
An AE 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.
The number of participants who experience an AE will be reported.
|
Up to approximately 37 weeks
|
|
Number of participants who discontinue study intervention due to an AE
Prazo: Up to approximately 21 weeks
|
An AE 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.
The number of participants who discontinue study intervention due to an AE will be reported.
|
Up to approximately 21 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 7962-037
- MK-7962-037 (Outro identificador: MSD)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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