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

Sponsor
Enanta Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04633187
Collaborator
(none)
200
Enrollment
60
Locations
2
Arms
32.8
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 7, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: EDP-938

Drug: EDP-938
EDP-938 800mg Dose adjustments will be made for subjects taking azole antifungals.
Placebo Comparator: Placebo

Drug: Placebo
Subjects will take EDP-938 matching placebo tablets once a day orally for 21 days

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects who develop Lower Respiratory Tract (LRTC) complication [Day 1 through Day 28]

Secondary Outcome Measures

  1. Change from baseline in RSV RNA viral load [Day 1 through Day 49]

  2. 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]

  3. Safety as measured by frequency of adverse events (AEs) [Day 1 through Day 49]

  4. Plasma PK Concentrations of EDP-938 [Day 0 through Day 21]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Augusta University Medical Center Augusta Georgia United States 30912
2 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
3 Hospital Universitario Austral Pilar Buenos Aires Argentina B1629AHJ
4 Hospital Italiano de Buenos Aires Buenos Aires Ciudad Autónoma De BuenosAires Argentina 1199ABB
5 Fundación Favaloro Buenos Aires Ciudad Autónoma De BuenosAires Argentina C1093AAS
6 Instituto Fides La Plata Ciudad Autónoma De BuenosAires Argentina 483 5051
7 Sanatorio Allende S.A. Córdoba Cordoba Argentina X5000JHQ
8 Hospital Britanico de Buenos Aires Buenos Aires Argentina C1280AEB
9 Westmead Hospital Westmead New South Wales Australia 2145
10 Hôpital de Jolimont La Louvière Belgium 7100
11 Chronos Pesquisa Clínica Brasília Distrito Federal Brazil 72145-450
12 Hospital de Clinicas de Porto Alegre (HCPA) - PPDS Porto Alegre Rio Grande Do Sul Brazil 90035
13 Hospital Universitário de Santa Maria Santa Maria Rio Grande Do Sul Brazil 97105-900
14 Fundação PIO XII Barretos Sao Paulo Brazil 14784
15 Hospital Alemão Oswaldo Cruz São Paulo Sao Paulo Brazil 01323-903
16 Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo São Paulo Sao Paulo Brazil 05403000
17 Toronto General Hospital Toronto Ontario Canada M5G 2C4
18 Toronto General Hospital Toronto Canada
19 Queen Mary Hospital Hong Kong Hong Kong China
20 Centro Medico Imbanaco de Cali S.A. Cali Valle Del Cauca Colombia
21 Hospital Pablo Tobón Uribe Medellín Colombia
22 CHU de Nice Nice Alpes-Maritimes France 06202
23 Hôtel Dieu -Angers Angers Maine-et-Loire France 49933
24 Hopital Cote de Nacre Caen France 14000
25 Hôpital Saint Antoine Paris France 75012
26 Centre Hospitalier Lyon Sud Pierre-Bénite France
27 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Rheinland-Pfalz Germany 55131
28 Attikon University General Hospital Athens Greece
29 Evangelismos General Hospital of Athens Athens Greece
30 Rambam Medical Center Haifa Israel 31096
31 Hadassah Medical Center Jerusalem Israel 91120
32 Sheba Medical Center Ramat Gan Israel 52621
33 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
34 ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN Brescia Lombardia Italy 25123
35 Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi Ancona Marche Italy 60020
36 A.O.U. Maggiore della Carità Novara Piemonte Italy 28100
37 Azienda ULSS 8 "Berica" - Ospedale San Bortolo Vicenza Veneto Italy 36100
38 Fondazione Policlinico Universitario A Gemelli Roma Italy 00168
39 Chungnam National University Hospital Daejeon Korea, Republic of 301-721
40 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
41 Samsung Medical Center Seoul Korea, Republic of
42 Gachon University Gil Medical Center Ulsan Korea, Republic of 682714
43 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi Gliwice Slaskie Poland
44 Uniwersyteckie Centrum Kliniczne Gdańsk Poland
45 Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie Szczecin Poland
46 Albert Alberts Stem Cell Transplant Centre Pretoria Gauteng South Africa 0044
47 FCRN Clinical Trial Centre (Pty) Ldt Vereeniging Gauteng South Africa 1935
48 WITS Clinical Research Site Johannesburg South Africa
49 ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet De Llobregat Barcelona Spain 08908
50 Hospital Universitario Virgen de La Arrixaca El Palmar Murcia Spain 30120
51 Hospital Clinic de Barcelona Barcelona Spain 08036
52 Hospital Universitario Virgen de Las Nieves Granada Spain 18014
53 Hospital Universitario Ramon y Cajal Madrid Spain 28034
54 Hospital Universitario 12 de Octubre Madrid Spain 28041
55 Hospital Regional Universitario de Malaga - Hospital General Málaga Spain 29010
56 Hospital Universitario Virgen del Rocio - PPDS Sevilla Spain 41013
57 Hospital Clinico Universitario de Valencia Valencia Spain 46026
58 Changhua Christian Medical Foundation Changhua Christian Hospital Changhua Taiwan 50006
59 Taipei Veterans General Hospital Taipei City Taiwan
60 Imperial College London United Kingdom W12 0HS

Sponsors and Collaborators

  • Enanta Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04633187
Other Study ID Numbers:
  • EDP 938-103
First Posted:
Nov 18, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Virus Diseases
Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Jun 1, 2022