A Study to Evaluate EDP 938 Regimens in Children With RSV (RSVPEDs)

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    90
  • sponsor
    Enanta Pharmaceuticals
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Updated on 18 May 2022
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Summary

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

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.

Details
Condition Respiratory Syncytial Virus (RSV)
Treatment Placebo, EDP-938
Clinical Study IdentifierNCT04816721
SponsorEnanta Pharmaceuticals
Last Modified on18 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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