Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
10 de setembro de 2021 atualizado por: MedImmune LLC
A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.
Tipo de estudo
Intervencional
Inscrição (Real)
31
Estágio
- Fase 1
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
Não mais velho que 2 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Previously healthy
- Age 24 months and younger at the time of randomization
- Gestational age of 36 weeks gestation and older
- Randomization within 24 hours after hospitalization
- Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization
Exclusion Criteria:
- Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
- Required intubation for ventilatory support
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
- Mechanical ventilation at any time prior to the onset of the current RSV infection
- Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
- Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
- Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
- Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Motavizumab, 3 mg/kg as a single intravenous dose
Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
|
|
Experimental: Motavizumab, 15 mg/kg as a single intravenous dose
Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
|
|
Experimental: Motavizumab, 30 mg/kg as a single intravenous dose
Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
|
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Outros nomes:
|
|
Comparador de Placebo: Placebo, as a single intravenous dose
Placebo, as a single intravenous dose administered on Day 0
|
Single dose of placebo administered intravenously (in the vein) on Day 0
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Prazo: From the start of treatment to 30 days after dosing
|
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
|
From the start of treatment to 30 days after dosing
|
|
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
Prazo: From the start of treatment to 30 days after dosing
|
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
|
From the start of treatment to 30 days after dosing
|
|
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
Prazo: From the start of treatment to 30 days after dosing
|
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
|
From the start of treatment to 30 days after dosing
|
|
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
Prazo: Day 2 and Day 30
|
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30.
Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
|
Day 2 and Day 30
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
Prazo: Immediately before dosing on Day 0
|
The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing).
Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
|
Immediately before dosing on Day 0
|
|
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
Prazo: Day 30
|
The serum anti-motavizumab antibody titers were measured in subjects on Day 30.
Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
|
Day 30
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Genevieve A Losonsky, MD, MedImmune LLC
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2004
Conclusão Primária (Real)
1 de janeiro de 2005
Conclusão do estudo (Real)
1 de janeiro de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
13 de setembro de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de setembro de 2005
Primeira postagem (Estimativa)
19 de setembro de 2005
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de setembro de 2021
Última verificação
1 de outubro de 2006
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MI-CP106
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