A Study to Evaluate EDP 938 Regimens in Children With RSV
Completed · Phase 2 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus (RSV)
In brief
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
Key facts
- Study ID
- NCT04816721
- Run by
- Enanta Pharmaceuticals, Inc
- People needed
- 99
- Starts
- 2022-04-26
- Expected to finish
- 2024-08-19
- Last updated by the study team
- 2025-07-28
Who can join
Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
- Memorial Care Miller Children's and Women's Hospital — Long Beach, California, United States
Full record on ClinicalTrials.gov
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