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

TerminadoFase 2ClinicalTrials.gov

ID: NCT04633187Tipo: INTERVENTIONALInicio: 7 de jul de 2021Fin estimado: 31 de may de 2023

Neurología Neumología Enfermedades Infecciosas

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Resumen

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.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

EDP-938

EDP-938 800mg Dose adjustments were made for subjects taking azole antifungals.

drug

Placebo

Subjects took EDP-938 matching placebo tablets once a day orally for 21 days

Ubicaciones

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

Patrocinadores

PrincipalEnanta Pharmaceuticals, Inc

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