Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
NCT ID: NCT04633187
Last Updated: 2024-08-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2021-07-07
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EDP-938
EDP-938
EDP-938 800mg
Dose adjustments were made for subjects taking azole antifungals.
Placebo
Placebo
Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Interventions
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EDP-938
EDP-938 800mg
Dose adjustments were made for subjects taking azole antifungals.
Placebo
Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
75 Years
ALL
No
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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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
Hospital Universitário de Santa Maria
Santa Maria, Rio Grande do Sul, Brazil
Fundação PIO XII
Barretos, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Toronto General Hospital
Toronto, Ontario, Canada
Queen Mary Hospital
Hong Kong, Hong Kong, China
Hospital Pablo Tobón Uribe
Medellín, , Colombia
CHU de Nice
Nice, Alpes-Maritimes, France
Hôtel Dieu -Angers
Angers, Maine-et-Loire, France
Hôpital Claude Huriez
Lille, Nord, France
Hopital Cote de Nacre
Caen, , France
Hôpital Saint Antoine
Paris, , France
Attikon University General Hospital
Athens, , Greece
Evangelismos General Hospital of Athens
Athens, , Greece
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, Lombardy, Italy
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, The Marches, Italy
Azienda ULSS 8 "Berica" - Ospedale San Bortolo
Vicenza, Veneto, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Fondazione Policlinico Universitario A Gemelli
Roma, , Italy
Instituto Nacional de Cancerologia
Mexico City, , Mexico
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi
Gliwice, Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Albert Alberts Stem Cell Transplant Centre
Pretoria, Gauteng, South Africa
FCRN Clinical Trial Centre (Pty) Ldt
Vereeniging, Gauteng, South Africa
WITS Clinical Research Site
Johannesburg, , South Africa
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Gachon University Gil Medical Center
Ulsan, , South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de San Pedro de Alcantara
Cáceres, Caceres, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, İzmir, Turkey (Türkiye)
Namik Kemal University
Tekirdağ, Tekirdağ, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , Turkey (Türkiye)
Imperial College
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EDP 938-103
Identifier Type: -
Identifier Source: org_study_id
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