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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04633187




Registration number
NCT04633187
Ethics application status
Date submitted
11/11/2020
Date registered
18/11/2020
Date last updated
13/09/2023

Titles & IDs
Public title
Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Who Are Infected With Acute Respiratory Syncytial Virus (RSV) 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
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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 will be made for subjects taking azole antifungals.

Treatment: Drugs: Placebo
Subjects will take 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
Proportion 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 by frequency of adverse events (AEs)
Timepoint [3] 0 0
Day 1 through Day 49
Secondary outcome [4] 0 0
Plasma PK Concentrations of EDP-938
Timepoint [4] 0 0
Day 0 through Day 21

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
Recruiting
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
1/04/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autónoma De BuenosAires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Belgium
State/province [6] 0 0
Antwerpen
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
La Louvière
Country [9] 0 0
Brazil
State/province [9] 0 0
Distrito Federal
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio Grande Do Sul
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
China
State/province [13] 0 0
Hong Kong
Country [14] 0 0
Colombia
State/province [14] 0 0
Valle Del Cauca
Country [15] 0 0
Colombia
State/province [15] 0 0
Medellín
Country [16] 0 0
France
State/province [16] 0 0
Alpes-Maritimes
Country [17] 0 0
France
State/province [17] 0 0
Maine-et-Loire
Country [18] 0 0
France
State/province [18] 0 0
Nord
Country [19] 0 0
France
State/province [19] 0 0
Caen
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Pierre-Bénite
Country [22] 0 0
Germany
State/province [22] 0 0
Baden-Württemberg
Country [23] 0 0
Germany
State/province [23] 0 0
Rheinland-Pfalz
Country [24] 0 0
Greece
State/province [24] 0 0
Athens
Country [25] 0 0
Israel
State/province [25] 0 0
Haifa
Country [26] 0 0
Israel
State/province [26] 0 0
Jerusalem
Country [27] 0 0
Israel
State/province [27] 0 0
Ramat Gan
Country [28] 0 0
Israel
State/province [28] 0 0
Tel Aviv
Country [29] 0 0
Italy
State/province [29] 0 0
Lombardia
Country [30] 0 0
Italy
State/province [30] 0 0
Marche
Country [31] 0 0
Italy
State/province [31] 0 0
Piemonte
Country [32] 0 0
Italy
State/province [32] 0 0
Veneto
Country [33] 0 0
Italy
State/province [33] 0 0
Firenze
Country [34] 0 0
Italy
State/province [34] 0 0
Roma
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Daejeon
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Ulsan
Country [38] 0 0
Mexico
State/province [38] 0 0
Mexico City
Country [39] 0 0
Poland
State/province [39] 0 0
Slaskie
Country [40] 0 0
Poland
State/province [40] 0 0
Gdansk
Country [41] 0 0
Poland
State/province [41] 0 0
Szczecin
Country [42] 0 0
South Africa
State/province [42] 0 0
Gauteng
Country [43] 0 0
South Africa
State/province [43] 0 0
Johannesburg
Country [44] 0 0
Spain
State/province [44] 0 0
Baleares
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Caceres
Country [47] 0 0
Spain
State/province [47] 0 0
Murcia
Country [48] 0 0
Spain
State/province [48] 0 0
Granada
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Málaga
Country [51] 0 0
Spain
State/province [51] 0 0
Sevilla
Country [52] 0 0
Spain
State/province [52] 0 0
Valencia
Country [53] 0 0
Taiwan
State/province [53] 0 0
Changhua
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taipei City
Country [55] 0 0
Turkey
State/province [55] 0 0
Izmir
Country [56] 0 0
Turkey
State/province [56] 0 0
Tekirdag
Country [57] 0 0
Turkey
State/province [57] 0 0
Samsun
Country [58] 0 0
United Kingdom
State/province [58] 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04633187
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04633187