A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ... | EligiMed

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)

CompletadoFase 2ClinicalTrials.gov

ID: NCT04816721Tipo: INTERVENTIONALInicio: 26 de abr de 2022Fin estimado: 19 de ago de 2024

Neumología Pediatría

Traducción no disponible, mostrando original

Resumen

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

Descripción detallada

This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

Elegibilidad

Edad mínima: 28 DaysEdad máxima: 36 MonthsSexo: ALL

Criterios de inclusión

Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to \<6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible.
Subjects diagnosed with RSV infection
Subjects with signs of an acute respiratory illness with onset ≤7 days for Part 1 and ≤5 days for Part 2 before the time of signing the ICF
In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Criterios de exclusión

Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
Receiving chronic oxygen therapy at home before admission
Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.

Intervenciones

drug

EDP-938

Oral suspension

drug

Placebo

Placebo oral suspension to match EDP-938

Ubicaciones

Clinica del Niño y la Familia

Mar del Plata, Buenos Aires, Argentina

Hospital Interzonal Dr Jose Penna

Bahía Blanca, Argentina

Clínica Privada del Sol

Buenos Aires, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Clinica Central S.A

Villa Regina, Argentina

Patrocinadores

PrincipalEnanta Pharmaceuticals, Inc

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