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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04816721




Registration number
NCT04816721
Ethics application status
Date submitted
23/03/2021
Date registered
25/03/2021

Titles & IDs
Public title
A Study to Evaluate EDP 938 Regimens in Children With RSV
Scientific title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
Secondary ID [1] 0 0
EDP 938-201
Universal Trial Number (UTN)
Trial acronym
RSVPEDs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV) 0 0
Condition category
Condition code

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

Experimental: EDP-938 - EDP-938, oral suspension, once daily for 5 days

Placebo comparator: Placebo - Matching placebo, orally, once daily for 5 days


Treatment: Drugs: EDP-938
Oral suspension

Treatment: Drugs: Placebo
Placebo oral suspension to match EDP-938
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC of EDP-938 (Part 1)
Timepoint [1] 0 0
Up to 5 days
Primary outcome [2] 0 0
Predose concentration of EDP-938 (Part 1)
Timepoint [2] 0 0
Up to 5 days
Primary outcome [3] 0 0
Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1)
Timepoint [3] 0 0
Up to 29 Days
Primary outcome [4] 0 0
Daily change from baseline in RSV shedding (Part 2)
Timepoint [4] 0 0
Up to 14 Days
Secondary outcome [1] 0 0
AUC for RSV RNA viral load (Part 1 and Part 2)
Timepoint [1] 0 0
Up to 14 Days
Secondary outcome [2] 0 0
Daily change in RSV shedding (Part 1)
Timepoint [2] 0 0
Up to 14 Days
Secondary outcome [3] 0 0
Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2)
Timepoint [3] 0 0
Up to 14 Days
Secondary outcome [4] 0 0
Time to RSV RNA viral load being undetectable (Part 1 and Part 2)
Timepoint [4] 0 0
Up to 14 Days
Secondary outcome [5] 0 0
AUC of EDP-938 (Part 2)
Timepoint [5] 0 0
Up to 5 Days
Secondary outcome [6] 0 0
Predose concentration of EDP-938 (Part 2)
Timepoint [6] 0 0
Up to 5 Days
Secondary outcome [7] 0 0
Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2)
Timepoint [7] 0 0
Up to 29 Days
Secondary outcome [8] 0 0
Time to discharge for hospitalized subjects (Part 2)
Timepoint [8] 0 0
Up to 29 Days
Secondary outcome [9] 0 0
Time to use of oxygen for hospitalized subjects who are not receiving oxygen at the time they receive the first dose of study drug (Part 2)
Timepoint [9] 0 0
Up to 29 Days
Secondary outcome [10] 0 0
Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement
Timepoint [10] 0 0
Up to 29 Days

Eligibility
Key inclusion criteria
* Male or female who is either =6 months to =36 months (for Age Group 1) or =28 days to <6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born =29 weeks of gestation to be eligible.
* Subjects diagnosed with RSV infection
* Subjects with signs of an acute respiratory illness with onset =7 days for Part 1 and =5 days for Part 2 before the time of signing the ICF
* In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
Minimum age
28 Days
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
* Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
* Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
* Receiving chronic oxygen therapy at home before admission
* Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (=37 weeks of gestation) and are less than 12 months of age
* In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.

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 administering the treatment/s
The people assessing the outcomes
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
26/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
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United States of America
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Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
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United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
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United States of America
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Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Bahía Blanca
Country [16] 0 0
Argentina
State/province [16] 0 0
Río Cuarto
Country [17] 0 0
Argentina
State/province [17] 0 0
Villa Regina
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
Curitiba
Country [20] 0 0
Brazil
State/province [20] 0 0
Ribeirão Preto
Country [21] 0 0
Germany
State/province [21] 0 0
Bundesland
Country [22] 0 0
Germany
State/province [22] 0 0
Erlangen
Country [23] 0 0
Germany
State/province [23] 0 0
Mainz
Country [24] 0 0
Germany
State/province [24] 0 0
Sankt Augustin
Country [25] 0 0
Israel
State/province [25] 0 0
Be'er Sheva
Country [26] 0 0
Israel
State/province [26] 0 0
Haifa
Country [27] 0 0
Israel
State/province [27] 0 0
Jerusalem
Country [28] 0 0
Israel
State/province [28] 0 0
Petach Tikva
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Mexico
State/province [30] 0 0
Prados
Country [31] 0 0
Mexico
State/province [31] 0 0
Puebla
Country [32] 0 0
Mexico
State/province [32] 0 0
Mexico City
Country [33] 0 0
Mexico
State/province [33] 0 0
Monterrey
Country [34] 0 0
Mexico
State/province [34] 0 0
Querétaro
Country [35] 0 0
New Zealand
State/province [35] 0 0
Wellington
Country [36] 0 0
Poland
State/province [36] 0 0
Bydgoszcz
Country [37] 0 0
Poland
State/province [37] 0 0
Lódz
Country [38] 0 0
Romania
State/province [38] 0 0
Bra?ov
Country [39] 0 0
Romania
State/province [39] 0 0
Târgu Mure?
Country [40] 0 0
Romania
State/province [40] 0 0
Bucharest
Country [41] 0 0
South Africa
State/province [41] 0 0
Durban
Country [42] 0 0
South Africa
State/province [42] 0 0
Johannesburg
Country [43] 0 0
South Africa
State/province [43] 0 0
Soweto
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Lleida
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Málaga
Country [48] 0 0
Spain
State/province [48] 0 0
Santiago De Compostela
Country [49] 0 0
Spain
State/province [49] 0 0
Tarragona
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taipei
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taoyuan
Country [52] 0 0
Taiwan
State/province [52] 0 0
Hsinchu
Country [53] 0 0
Taiwan
State/province [53] 0 0
Kaohsiung
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taichung
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Nottinghamshire
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Liverpool
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Sheffield

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04816721