A Study to Evaluate EDP 938 Regimens in Children With RSV

Last updated: October 11, 2024
Sponsor: Enanta Pharmaceuticals, Inc
Overall Status: Completed

Phase

2

Condition

Respiratory Syncytial Virus (Rsv)

Treatment

Placebo

EDP-938

Clinical Study ID

NCT04816721
EDP 938-201
  • Ages 28-36
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 daysto <6 months (for Age Group 2), defined at the time of randomization. Subjects inAge 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 1and ≤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 tocomply with protocol requirements, instructions, and protocol-stated restrictions,and the subject is likely to complete the study as planned

Exclusion

Exclusion Criteria:

  • Use of or anticipated need for invasive mechanical ventilation, cardiopulmonarybypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who arenot expected to survive the current illness

  • Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virusinfection or use of an immunosuppressive medication except immunoglobulin Adeficiency)

  • Receipt of (within 12 months before Screening) or on a waiting list for a bonemarrow, stem cell, or solid organ transplant, or who received radiation orchemotherapy (within 12 months before screening)

  • Receiving chronic oxygen therapy at home before admission

  • Subjects whose mother received an investigational RSV vaccination while pregnantwith the subject if they were born at term (≥37 weeks of gestation) and are lessthan 12 months of age

  • In Part 2, subjects dosed with an investigational or approved medication that isintended to prevent or treat RSV infection within the following times before thefirst dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody;RSV vaccines 12 months.

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 26, 2022
Estimated Completion Date:
August 19, 2024

Study 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.

Connect with a study center

  • Clinica del Niño y la Familia

    Mar Del Plata, Buenos Aires
    Argentina

    Site Not Available

  • Hospital Interzonal Dr Jose Penna

    Bahía Blanca,
    Argentina

    Site Not Available

  • Clínica Privada del Sol

    Buenos Aires, C1425
    Argentina

    Site Not Available

  • Instituto Medico Rio Cuarto

    Río Cuarto,
    Argentina

    Site Not Available

  • Clinica Central S.A

    Villa Regina,
    Argentina

    Site Not Available

  • Sydney Children's Hospital - Randwick

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Southport,
    Australia

    Site Not Available

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, Rio Grande Do Sul 99010
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035
    Brazil

    Site Not Available

  • Universidade Federal do Paraná - Hospital de Clínicas

    Curitiba, 80060-900
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto, 14015-010
    Brazil

    Site Not Available

  • Universitätsklinikum Gießen und Marburg - Gießen

    Marburg, Bundesland 35043
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Site Not Available

  • University Hospital Mainz

    Mainz,
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin,
    Germany

    Site Not Available

  • Soroka University Medical Center

    Be'er Sheva,
    Israel

    Site Not Available

  • Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Health Care

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah University Hospital Mount Scopu

    Jerusalem,
    Israel

    Site Not Available

  • Schneider Children's Medical Center Of Israel

    Petach Tikva, 4920235
    Israel

    Site Not Available

  • Inje University Sanggye Paik Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul, 2447
    Korea, Republic of

    Site Not Available

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 1830
    Korea, Republic of

    Site Not Available

  • Panamerican Clinical Research Mexico - Guadalajara

    Guadalajara, Prados 44670
    Mexico

    Site Not Available

  • El Cielo Medical Center RSB, S.C.

    La Paz, Puebla
    Mexico

    Site Not Available

  • Hospital Infantil De Mexico Federico Gomez

    Mexico City,
    Mexico

    Site Not Available

  • Instituto Nacional de Pediatría

    Mexico City, 04530
    Mexico

    Site Not Available

  • Karla Adriana Espinosa Bautista

    Mexico City,
    Mexico

    Site Not Available

  • IESCI Clinical Research

    Monterrey,
    Mexico

    Site Not Available

  • PanAmerican Clinical Research

    Querétaro,
    Mexico

    Site Not Available

  • SMIQ S de R.L de C.V

    Querétaro,
    Mexico

    Site Not Available

  • Wellington Regional Hospital

    Newtown, Wellington
    New Zealand

    Site Not Available

  • IN-VIVO Bydgoszcz

    Bydgoszcz,
    Poland

    Site Not Available

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

    Łódź,
    Poland

    Site Not Available

  • Spital Clinic de Urgenta Pentru Copii Brasov

    Braşov, Brașov
    Romania

    Site Not Available

  • Spitalul Clinic Judetean De Urgenta Târgu Mureș

    Târgu-Mureş, Târgu Mureș
    Romania

    Site Not Available

  • Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"

    Bucharest,
    Romania

    Site Not Available

  • Life Westville Hospital

    Westville, Durban
    South Africa

    Site Not Available

  • Rahima Moosa Mother and Child Hospital

    Johannesburg,
    South Africa

    Site Not Available

  • Wits Clinical Research

    Soweto, 2013
    South Africa

    Site Not Available

  • Hospital Germans Trias i Pujol

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Arnau de Vilanova

    Lleida,
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Quirónsalud Madrid

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Madrid,
    Spain

    Site Not Available

  • Unidad de Ensayos Clínicos Pediátricos

    Madrid,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Santiago

    Santiago De Compostela,
    Spain

    Site Not Available

  • Hospital Universitario Joan XXIII de Tarragona

    Tarragona,
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei city, Taipei 100229
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation

    Taoyuan City, Taoyuan 333
    Taiwan

    Site Not Available

  • Hsinchu Mackay Memorial Hospital

    Hsinchu,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung,
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung,
    Taiwan

    Site Not Available

  • Taipei Mackay Memorial Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Alder Hey Children's NHS Foundation Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Sheffield Children's NHS Foundation Trust

    Sheffield,
    United Kingdom

    Site Not Available

  • Memorial Care Miller Children's and Women's Hospital

    Long Beach, California 90806
    United States

    Site Not Available

  • University of California Los Angeles (UCLA)

    Los Angeles, California 90095
    United States

    Site Not Available

  • UC Davis

    Sacramento, California 95817
    United States

    Site Not Available

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • University of Florida Health

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Nemours Children's Hospital

    Orlando, Florida 32827
    United States

    Site Not Available

  • South Tampa Center for Advanced Healthcare

    Tampa, Florida 33606
    United States

    Site Not Available

  • Rexburg Pediatrics

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Norton Children's Research Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • MedPharmics - Lafayette

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • LSU Health

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Willis-Knighton Health System

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Office of Craig A. Spiegel, MD

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Coastal Pediatric Associates - Mount Pleasant

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Children's Health Specialty Center Dallas Campus

    Dallas, Texas 75207
    United States

    Site Not Available

  • Pediatric Research of Charlottesville

    Charlottesville, Virginia 22902
    United States

    Site Not Available

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