A Study to Evaluate EDP 938 Regimens in Children With RSV

Respiratory Syncytial Virus (RSV) Clinical Trial

— RSVPEDs  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816721
• Other study ID #: EDP 938-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 26, 2022
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Enanta Pharmaceuticals, Inc
• Contact: Enanta Pharmaceuticals, Inc
• Phone: (617) 607-0800
• Email: charris[@]enanta.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 36 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

Drug:
• EDP-938
Oral suspension
• Placebo
Placebo oral suspension to match EDP-938

Locations

Country	Name	City	State
Argentina	Hospital Interzonal Dr Jose Penna	Bahía Blanca
Argentina	Clínica Privada del Sol	Buenos Aires
Argentina	Clinica del Niño y la Familia	Mar Del Plata	Buenos Aires
Argentina	Instituto Medico Rio Cuarto	Río Cuarto
Argentina	Clinica Central S.A	Villa Regina
Australia	Sydney Children's Hospital - Randwick	Randwick	New South Wales
Australia	Gold Coast University Hospital	Southport
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
Brazil	Universidade Federal do Paraná - Hospital de Clínicas	Curitiba
Brazil	Instituto Méderi de Pesquisa e Saúde	Passo Fundo	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	University Hospital Mainz	Mainz
Germany	Universitätsklinikum Gießen und Marburg - Gießen	Marburg	Bundesland
Germany	Asklepios Klinik Sankt Augustin	Sankt Augustin
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care	Haifa
Israel	Hadassah University Hospital Mount Scopu	Jerusalem
Israel	Schneider Children's Medical Center Of Israel	Petach Tikva
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Mexico	Panamerican Clinical Research Mexico - Guadalajara	Guadalajara	Prados
Mexico	El Cielo Medical Center RSB, S.C.	La Paz	Puebla
Mexico	Hospital Infantil De Mexico Federico Gomez	Mexico City
Mexico	Instituto Nacional de Pediatría	Mexico City
Mexico	Karla Adriana Espinosa Bautista	Mexico City
Mexico	IESCI Clinical Research	Monterrey
Mexico	PanAmerican Clinical Research	Querétaro
Mexico	SMIQ S de R.L de C.V	Querétaro
New Zealand	Wellington Regional Hospital	Newtown	Wellington
Poland	IN-VIVO Bydgoszcz	Bydgoszcz
Poland	Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi	Lódz
Romania	Spital Clinic de Urgenta Pentru Copii Brasov	Brasov	Bra?ov
Romania	Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"	Bucharest
Romania	Spitalul Clinic Judetean De Urgenta Târgu Mure?	Târgu-Mures	Târgu Mure?
South Africa	Rahima Moosa Mother and Child Hospital	Johannesburg
South Africa	Wits Clinical Research	Soweto
South Africa	Life Westville Hospital	Westville	Durban
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario Arnau de Vilanova	Lleida
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Madrid
Spain	Hospital Universitario Quirónsalud Madrid	Madrid
Spain	Hospital Universitario Severo Ochoa	Madrid
Spain	Unidad de Ensayos Clínicos Pediátricos	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Universitario Joan XXIII de Tarragona	Tarragona
Taiwan	Hsinchu Mackay Memorial Hospital	Hsinchu
Taiwan	Chang Gung Memorial Hospital - Kaohsiung Branch	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taipei Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei city	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation	Taoyuan City	Taoyuan
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool
United Kingdom	St. George's University Hospitals NHS Foundation Trust	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield
United States	Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine	Boston	Massachusetts
United States	Office of Craig A. Spiegel, MD	Bridgeton	Missouri
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Pediatric Research of Charlottesville	Charlottesville	Virginia
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Children's Health Specialty Center Dallas Campus	Dallas	Texas
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	University of Florida Health	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	MedPharmics - Lafayette	Lafayette	Louisiana
United States	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	Norton Children's Research Institute	Louisville	Kentucky
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Nemours Children's Hospital	Orlando	Florida
United States	Rexburg Pediatrics	Rexburg	Idaho
United States	UC Davis	Sacramento	California
United States	LSU Health	Shreveport	Louisiana
United States	Willis-Knighton Health System	Shreveport	Louisiana
United States	Coastal Pediatric Associates - Mount Pleasant	Summerville	South Carolina
United States	South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	Toledo Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Germany,  Israel,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Romania,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of EDP-938 (Part 1)		Up to 5 days
Primary	Predose concentration of EDP-938 (Part 1)		Up to 5 days
Primary	Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1)		Up to 29 Days
Primary	Daily change from baseline in RSV shedding (Part 2)		Up to 14 Days
Secondary	AUC for RSV RNA viral load (Part 1 and Part 2)		Up to 14 Days
Secondary	Daily change in RSV shedding (Part 1)		Up to 14 Days
Secondary	Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2)		Up to 14 Days
Secondary	Time to RSV RNA viral load being undetectable (Part 1 and Part 2)		Up to 14 Days
Secondary	AUC of EDP-938 (Part 2)		Up to 5 Days
Secondary	Predose concentration of EDP-938 (Part 2)		Up to 5 Days
Secondary	Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2)		Up to 29 Days
Secondary	Time to discharge for hospitalized subjects (Part 2)		Up to 29 Days
Secondary	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
Secondary	Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement		Up to 29 Days