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

Respiratory Syncytial Virus Infections Clinical Trial

— RSVTx  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04633187
• Other study ID #: EDP 938-103
• Status: Terminated
• Phase: Phase 2
• Start date: July 7, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: July 2023
• Source: Enanta Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 28, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• EDP-938
EDP-938 800mg Dose adjustments will be made for subjects taking azole antifungals.
• Placebo
Subjects will take EDP-938 matching placebo tablets once a day orally for 21 days

Locations

Country	Name	City	State
Argentina	Fundación Favaloro	Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	Hospital Britanico de Buenos Aires	Buenos Aires
Argentina	Sanatorio Allende S.A.	Córdoba	Cordoba
Argentina	Instituto Fides	La Plata	Ciudad Autónoma De BuenosAires
Belgium	Institute Jules Bordet	Anderlecht	Brussels
Belgium	UZ Antwerpen	Edegem	Antwerpen
Belgium	Hôpital de Jolimont	La Louvière
Brazil	Fundação PIO XII	Barretos	Sao Paulo
Brazil	Chronos Pesquisa Clínica	Brasília	Distrito Federal
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	Hospital Alemão Oswaldo Cruz	São Paulo	Sao Paulo
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	Sao Paulo
Canada	Toronto General Hospital	Toronto	Ontario
China	Queen Mary Hospital	Hong Kong	Hong Kong
Colombia	Hospital Pablo Tobón Uribe	Medellín
France	Hôtel Dieu -Angers	Angers	Maine-et-Loire
France	Hopital Cote de Nacre	Caen
France	Hôpital Claude Huriez	Lille	Nord
France	CHU de Nice	Nice	Alpes-Maritimes
France	Hôpital Saint Antoine	Paris
Greece	Attikon University General Hospital	Athens
Greece	Evangelismos General Hospital of Athens	Athens
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi	Ancona	Marche
Italy	ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN	Brescia	Lombardia
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	A.O.U. Maggiore della Carità	Novara	Piemonte
Italy	Fondazione Policlinico Universitario A Gemelli	Roma
Italy	Azienda ULSS 8 "Berica" - Ospedale San Bortolo	Vicenza	Veneto
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Gachon University Gil Medical Center	Ulsan
Mexico	Instituto Nacional de Cancerologia	Mexico City
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi	Gliwice	Slaskie
South Africa	WITS Clinical Research Site	Johannesburg
South Africa	Albert Alberts Stem Cell Transplant Centre	Pretoria	Gauteng
South Africa	FCRN Clinical Trial Centre (Pty) Ldt	Vereeniging	Gauteng
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de San Pedro de Alcantara	Cáceres	Caceres
Spain	Hospital Universitario Virgen de La Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Regional Universitario de Malaga - Hospital General	Málaga
Spain	Hospital General Universitario Morales Meseguer	Murcia
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Baleares
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	Changhua
Taiwan	Taipei Veterans General Hospital	Taipei City
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Bornova	Izmir
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi	Samsun
Turkey	Namik Kemal University	Tekirdag	Tekirdag
United Kingdom	Imperial College	London
United States	Augusta University Medical Center	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  China,  Colombia,  France,  Greece,  Israel,  Italy,  Korea, Republic of,  Mexico,  Poland,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who develop Lower Respiratory Tract (LRTC) complication		Day 1 through Day 28
Secondary	Change from baseline in RSV RNA viral load		Day 1 through Day 49
Secondary	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
Secondary	Safety as measured by frequency of adverse events (AEs)		Day 1 through Day 49
Secondary	Plasma PK Concentrations of EDP-938		Day 0 through Day 21