Summary

Eligibility
for people ages up to 36 months (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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)

Details

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.

Keywords

Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, RSV, Pediatric study, EDP-938

Eligibility

You can join if…

Open to people ages up to 36 months

  • Male or female who is either: born ≥37 weeks of gestation and is age ≥28 days to ≤36 months, defined at the time of randomization, or born <37 weeks of gestation and is age ≥6 months to ≤36 months defined at the time of randomization
  • 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

You CAN'T join if...

  • Use of or anticipated need for intensive monitoring and associated medical care
  • Underlying immune deficiency, eg, 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

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • University of California Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Enanta Pharmaceuticals, Inc
Links
Sign up for this study
ID
NCT04816721
Phase
Phase 2 Respiratory Syncytial Virus Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated