Last updated 11 months ago

A Study to Evaluate EDP 938 Regimens in Children With RSV

90 patients around the world

Available in Argentina, Mexico, United States, Spain

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.

Enanta Pharmaceuticals

90Patients around the world

Requirements for the patient

To 36 Months

All Gender

Medical requirements

: 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 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
Receiving an investigational or approved medication that is intended to prevent or treat RSV infection within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication. RSV-specific monoclonal antibodies are not prohibited in Part 1.

StudyRSVPEDs

SponsorEnanta Pharmaceuticals

Study typeInterventional

Requirements

To 36 MonthsAll Gender

Unique study IDclinicaltrials.gov

NCT04816721