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Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

NCT04633187•Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This was a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

Eligibility

Age

16 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen
•Absolute lymphocyte count (ALC) \<500 cells/ µL in allogeneic HCT recipients. Absolute lymphocyte count (ALC) \<300 cells/ µL in autologous HCT recipients.
•Laboratory confirmed RSV diagnosis from a respiratory sample obtained within 3 days before signing the ICF.
•New onset of at least one of the following respiratory symptoms within 3 days before signing the ICF: nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically (associated with a previously existing diagnosis \[eg, chronic rhinorrhea, chronic lung disease\]) in the 3 days before signing the ICF or at Screening.
•No evidence of new abnormalities consistent with LRTI on a chest imaging (chest x-ray and/or computed tomography) performed in the 2 days before signing the ICF or at the Screening visit if there is no chest X-ray and/or computed tomography available in the 2 days before signing the ICF.
•Oxygen saturation \>95% on room air.
•A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
•A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria

•Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator.
•Known to be concurrently infected with other respiratory viruses (eg, severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] or other coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus) within 7 days before signing the ICF, as determined by local testing.
•Clinically significant viremia, bacteremia, or fungemia, or bacterial or fungal pneumonia within 2 weeks before signing the ICF that has not been adequately treated, as determined by the Investigator.
•Known positive human immunodeficiency virus (HIV).
•Any clinical manifestation resulting in QT prolongation.

Locations (64)

Augusta University Medical Center

Augusta, Georgia, United States

Fundación Favaloro

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Instituto Fides

La Plata, Ciudad Autónoma de BuenosAires, Argentina

Sanatorio Allende S.A.

Córdoba, Córdoba Province, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

UZ Antwerpen

Edegem, Antwerpen, Belgium

Institute Jules Bordet

Anderlecht, Brussels Capital, Belgium

Hôpital de Jolimont

La Louvière, Belgium

Chronos Pesquisa Clínica

Brasília, Federal District, Brazil

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, Brazil

Key Dates

Start Date

July 7, 2021

Primary Completion Date

May 31, 2023

Completion Date

May 31, 2023

Last Updated

August 22, 2024

Enrollment

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938

DRUG

Placebo

DRUG

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset