A Study to Evaluate EDP 938 Regimens in Children With RSV
NCT ID: NCT04816721
Last Updated: 2025-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2022-04-26
2024-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EDP-938
EDP-938, oral suspension, once daily for 5 days
EDP-938
Oral suspension
Placebo
Matching placebo, orally, once daily for 5 days
Placebo
Placebo oral suspension to match EDP-938
Interventions
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EDP-938
Oral suspension
Placebo
Placebo oral suspension to match EDP-938
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
28 Days
36 Months
ALL
No
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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Memorial Care Miller Children's and Women's Hospital
Long Beach, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
Nemours Children's Hospital
Orlando, Florida, United States
South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
Rexburg Pediatrics
Rexburg, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Norton Children's Research Institute
Louisville, Kentucky, United States
MedPharmics - Lafayette
Lafayette, Louisiana, United States
LSU Health
Shreveport, Louisiana, United States
Willis-Knighton Health System
Shreveport, Louisiana, United States
Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine
Boston, Massachusetts, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Children's Health Specialty Center Dallas Campus
Dallas, Texas, United States
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
Sydney Children's Hospital - Randwick
Randwick, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Gold Coast University Hospital
Southport, , Australia
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Federal do Paraná - Hospital de Clínicas
Curitiba, , Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, , Brazil
Universitätsklinikum Gießen und Marburg - Gießen
Marburg, Bundesland, Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin, , Germany
Soroka University Medical Center
Beersheba, , Israel
Rambam Health Care
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Hadassah University Hospital Mount Scopu
Jerusalem, , Israel
Schneider Children's Medical Center Of Israel
Petah Tikva, , Israel
Panamerican Clinical Research Mexico - Guadalajara
Guadalajara, Prados, Mexico
Instituto Nacional de Pediatría
Mexico City, , Mexico
Hospital Infantil De Mexico Federico Gomez
Mexico City, , Mexico
Karla Adriana Espinosa Bautista
Mexico City, , Mexico
IESCI Clinical Research
Monterrey, , Mexico
PanAmerican Clinical Research
Querétaro, , Mexico
SMIQ S de R.L de C.V
Querétaro, , Mexico
Wellington Regional Hospital
Newtown, Wellington Region, New Zealand
IN-VIVO Bydgoszcz
Bydgoszcz, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, , Poland
Spital Clinic de Urgenta Pentru Copii Brasov
Brasov, Brașov County, Romania
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu Mureş, Târgu Mureș, Romania
Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"
Bucharest, , Romania
Life Westville Hospital
Westville, Durban, South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, , South Africa
Wits Clinical Research
Soweto, , South Africa
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario Arnau de Vilanova
Lleida, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , Spain
Hospital Universitario Quirónsalud Madrid
Madrid, , Spain
Hospital Universitario Severo Ochoa
Madrid, , Spain
Unidad de Ensayos Clínicos Pediátricos
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Joan XXIII de Tarragona
Tarragona, , Spain
National Taiwan University Hospital
Taipei City, Taipei, Taiwan
Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Taoyuan, Taoyuan, Taiwan
Hsinchu Mackay Memorial Hospital
Hsinchu, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taipei Mackay Memorial Hospital
Taipei, , Taiwan
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EDP 938-201
Identifier Type: -
Identifier Source: org_study_id
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