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

NCT04633187 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: EDP 938-103
• Study Type: interventional
• Target: 9
• Locations: 19 countries
• Sites: 64

Brief Summary

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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication

  Day 1 through Day 28

Secondary Outcomes (4)

• 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

Study Arms (2)

EDP-938

EXPERIMENTAL

Drug: EDP-938

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EDP-938 DRUG

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

EDP-938

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (64)

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Fundación Favaloro

Buenos Aires, Ciudad Autónoma de BuenosAires, C1093AAS, Argentina

Location

Instituto Fides

La Plata, Ciudad Autónoma de BuenosAires, 483 5051, Argentina

Location

Sanatorio Allende S.A.

Córdoba, Córdoba Province, X5000JHQ, Argentina

Location

Hospital Britanico de Buenos Aires

Buenos Aires, C1280AEB, Argentina

Location

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

Institute Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

Location

Hôpital de Jolimont

La Louvière, 7100, Belgium

Location

Chronos Pesquisa Clínica

Brasília, Federal District, 72145-450, Brazil

Location

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, 90035, Brazil

Location

Hospital Universitário de Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

Fundação PIO XII

Barretos, São Paulo, 14784, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, 01323-903, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

Hospital Pablo Tobón Uribe

Medellín, Colombia

Location

CHU de Nice

Nice, Alpes-Maritimes, 06202, France

Location

Hôtel Dieu -Angers

Angers, Maine-et-Loire, 49933, France

Location

Hôpital Claude Huriez

Lille, Nord, 59037, France

Location

Hopital Cote de Nacre

Caen, 14000, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Attikon University General Hospital

Athens, Greece

Location

Evangelismos General Hospital of Athens

Athens, Greece

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

Brescia, Lombardy, 25123, Italy

Location

A.O.U. Maggiore della Carità

Novara, Piedmont, 28100, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

Ancona, The Marches, 60020, Italy

Location

Azienda ULSS 8 "Berica" - Ospedale San Bortolo

Vicenza, Veneto, 36100, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Roma, 00168, Italy

Location

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi

Gliwice, Silesian Voivodeship, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Albert Alberts Stem Cell Transplant Centre

Pretoria, Gauteng, 0044, South Africa

Location

FCRN Clinical Trial Centre (Pty) Ldt

Vereeniging, Gauteng, 1935, South Africa

Location

WITS Clinical Research Site

Johannesburg, South Africa

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Gachon University Gil Medical Center

Ulsan, 682714, South Korea

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital de San Pedro de Alcantara

Cáceres, Caceres, 10003, Spain

Location

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, 29010, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46026, Spain

Location

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Ege Universitesi Tip Fakultesi Hastanesi

Bornova, İzmir, Turkey (Türkiye)

Location

Namik Kemal University

Tekirdağ, Tekirdağ, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, Turkey (Türkiye)

Location

Imperial College

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Study Director
• Organization: Enanta Pharmaceuticals

enquiries@enanta.com

617-607-0800

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: July 7, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-07

Locations

GB (1); CO (1); TW (2); CA (1); BR (6); PL (2); FR (5); BE (3); ME (1); AR (4); IL (4); ZA (3); CN (1); KR (5); US (1); GR (2); IT (6); ES (13); TU (3)