A Study to Evaluate EDP 938 Regimens in Children With RSV
- Registration Number
- NCT04816721
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo, orally, once daily for 5 days EDP-938 EDP-938 EDP-938, oral suspension, once daily for 5 days
- Primary Outcome Measures
Name Time Method Daily change from baseline in RSV shedding Up to 14 Days Predose concentration of EDP-938 (Part 1) Up to 5 days AUC of EDP-938 (Part 1) Up to 5 days Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1) Up to 29 Days
- Secondary Outcome Measures
Name Time Method Predose concentration of EDP-938 (Part 2) Up to 5 Days Daily change in RSV shedding (Part 1) Up to 14 Days Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2) Up to 14 Days Time to RSV RNA viral load being undetectable (Part 1 and Part 2) Up to 14 Days Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement Up to 29 Days Time to use of oxygen for hospitalized subjects who are not receiving oxygen at the time they receive the first dose of study drug (Part 2) Up to 29 Days Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2) Up to 29 Days AUC for RSV RNA viral load (Part 1 and Part 2) Up to 14 Days AUC of EDP-938 (Part 2) Up to 5 Days Time to discharge for hospitalized subjects (Part 2) Up to 29 Days
Trial Locations
- Locations (78)
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
UC 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
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