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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04633187




Registration number
NCT04633187
Ethics application status
Date submitted
11/11/2020
Date registered
18/11/2020
Date last updated
22/08/2024

Titles & IDs
Public title
Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
Scientific 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
Secondary ID [1] 0 0
EDP 938-103
Universal Trial Number (UTN)
Trial acronym
RSVTx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EDP-938
Treatment: Drugs - Placebo

Experimental: EDP-938 -

Placebo comparator: Placebo -


Treatment: Drugs: EDP-938
EDP-938 800mg

Dose adjustments were made for subjects taking azole antifungals.

Treatment: Drugs: Placebo
Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication
Timepoint [1] 0 0
Day 1 through Day 28
Secondary outcome [1] 0 0
Change From Baseline in RSV RNA Viral Load
Timepoint [1] 0 0
Day 1 through Day 49
Secondary outcome [2] 0 0
Proportion of Subjects Progressing to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality
Timepoint [2] 0 0
Day 1 through Day 49
Secondary outcome [3] 0 0
Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event
Timepoint [3] 0 0
Day 1 through Day 49
Secondary outcome [4] 0 0
Plasma PK Concentrations of EDP-938 800mg
Timepoint [4] 0 0
Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autónoma de BuenosAires
Country [3] 0 0
Argentina
State/province [3] 0 0
Córdoba Province
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerpen
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels Capital
Country [7] 0 0
Belgium
State/province [7] 0 0
La Louvière
Country [8] 0 0
Brazil
State/province [8] 0 0
Federal District
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio Grande do Sul
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
China
State/province [12] 0 0
Hong Kong
Country [13] 0 0
Colombia
State/province [13] 0 0
Medellín
Country [14] 0 0
France
State/province [14] 0 0
Alpes-Maritimes
Country [15] 0 0
France
State/province [15] 0 0
Maine-et-Loire
Country [16] 0 0
France
State/province [16] 0 0
Nord
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Israel
State/province [20] 0 0
Haifa
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Ramat Gan
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Aviv
Country [24] 0 0
Italy
State/province [24] 0 0
Lombardy
Country [25] 0 0
Italy
State/province [25] 0 0
Piedmont
Country [26] 0 0
Italy
State/province [26] 0 0
The Marches
Country [27] 0 0
Italy
State/province [27] 0 0
Veneto
Country [28] 0 0
Italy
State/province [28] 0 0
Florence
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Mexico
State/province [30] 0 0
Mexico City
Country [31] 0 0
Poland
State/province [31] 0 0
Silesian Voivodeship
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
South Africa
State/province [33] 0 0
Gauteng
Country [34] 0 0
South Africa
State/province [34] 0 0
Johannesburg
Country [35] 0 0
South Korea
State/province [35] 0 0
Daejeon
Country [36] 0 0
South Korea
State/province [36] 0 0
Seoul
Country [37] 0 0
South Korea
State/province [37] 0 0
Ulsan
Country [38] 0 0
Spain
State/province [38] 0 0
Balearic Islands
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Caceres
Country [41] 0 0
Spain
State/province [41] 0 0
Murcia
Country [42] 0 0
Spain
State/province [42] 0 0
Granada
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Málaga
Country [45] 0 0
Spain
State/province [45] 0 0
Seville
Country [46] 0 0
Spain
State/province [46] 0 0
Valencia
Country [47] 0 0
Taiwan
State/province [47] 0 0
Changhua
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Turkey (Türkiye)
State/province [49] 0 0
Izmir
Country [50] 0 0
Turkey (Türkiye)
State/province [50] 0 0
Tekirdag
Country [51] 0 0
Turkey (Türkiye)
State/province [51] 0 0
Samsun
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Enanta Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Enanta Pharmaceuticals, Inc
Address 0 0
Enanta Pharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Enanta Pharmaceuticals, Inc
Address 0 0
Country 0 0
Phone 0 0
(617) 607-0800
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04633187