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

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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: EDP-938; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Hospital Britanico de Buenos Aires
  • Ciudad Autónoma De BuenosAires
    • Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1093AAS
      • Fundacion Favaloro
    • La Plata, Ciudad Autónoma De BuenosAires, Argentina, 483 5051
      • Instituto FIDES
  • Cordoba
    • Córdoba, Cordoba, Argentina, X5000JHQ
      • Sanatorio Allende S.A.
• Belgium
  • La Louvière, Belgium, 7100
    • Hopital de Jolimont
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • UZ Antwerpen
  • Brussels
    • Anderlecht, Brussels, Belgium, 1070
      • Institute Jules Bordet
• Brazil
  • Distrito Federal
    • Brasília, Distrito Federal, Brazil, 72145-450
      • Chronos Pesquisa Clínica
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
    • Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
      • Hospital Universitario de Santa Maria
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784
      • Fundação Pio XII
    • São Paulo, Sao Paulo, Brazil, 01323-903
      • Hospital Alemao Oswaldo Cruz
    • São Paulo, Sao Paulo, Brazil, 05403000
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Queen Mary Hospital
• Colombia
  • Medellín, Colombia
    • Hospital Pablo Tobon Uribe
• France
  • Caen, France, 14000
    • Hôpital Côte de Nacre
  • Paris, France, 75012
    • Hôpital Saint Antoine
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • CHU de NICE
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49933
      • Hôtel Dieu -Angers
  • Nord
    • Lille, Nord, France, 59037
      • Hopital Claude Huriez
• Greece
  • Athens, Greece
    • Evangelismos General Hospital of Athens
  • Athens, Greece
    • Attikon University General Hospital
• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A Gemelli
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
  • Marche
    • Ancona, Marche, Italy, 60020
      • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
  • Piemonte
    • Novara, Piemonte, Italy, 28100
      • A.O.U. Maggiore della Carita
  • Veneto
    • Vicenza, Veneto, Italy, 36100
      • Azienda ULSS 8 "Berica" - Ospedale San Bortolo
• Korea, Republic of
  • Daejeon, Korea, Republic of, 301-721
    • Chungnam national university hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Ulsan, Korea, Republic of, 682714
    • Gachon University Gil Medical Center
• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional De Cancerologia
• Poland
  • Gdańsk, Poland
    • Uniwersyteckie Centrum Kliniczne
  • Slaskie
    • Gliwice, Slaskie, Poland
      • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi
• South Africa
  • Johannesburg, South Africa
    • WITS Clinical Research Site
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0044
      • Albert Alberts Stem Cell Transplant Centre
    • Vereeniging, Gauteng, South Africa, 1935
      • FCRN Clinical Trial Centre (Pty) Ldt
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga - Hospital General
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio - PPDS
  • Valencia, Spain, 46026
    • Hospital Clinico Universitario de Valencia
  • Baleares
    • Palma De Mallorca, Baleares, Spain, 07010
      • Hospital Universitario Son Espases
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
      • ICO l'Hospitalet - Hospital Duran i Reynals
  • Caceres
    • Cáceres, Caceres, Spain, 10003
      • Hospital de San Pedro de Alcantara
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de la Arrixaca
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Medical Foundation Changhua Christian Hospital
  • Taipei City, Taiwan
    • Taipei Veterans General Hospital
• Turkey
  • Samsun, Turkey
    • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  • Izmir
    • Bornova, Izmir, Turkey
      • Ege Universitesi Tip Fakultesi Hastanesi
  • Tekirdag
    • Tekirdağ, Tekirdag, Turkey
      • Namik Kemal University
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Imperial College
• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Experimental: EDP-938	Drug: EDP-938; EDP-938 800mg Dose adjustments were made for subjects taking azole antifungals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication	Day 1 through Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in RSV RNA Viral Load	Day 1 through Day 49
Proportion of Subjects Progressing to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality	Day 1 through Day 49
Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event	Day 1 through Day 49
Plasma PK Concentrations of EDP-938 800mg	Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Virus Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: EDP 938-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No