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RSVPEDs: A Study to Evaluate EDP 938 Regimens in Children With RSV

Sponsor
Enanta Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04816721
Collaborator
(none)
90
Enrollment
48
Locations
2
Arms
19.2
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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)
Actual Study Start Date :
Apr 26, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: EDP-938

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

Drug: EDP-938
Oral suspension
Placebo Comparator: Placebo

Matching placebo, orally, once daily for 5 days

Drug: Placebo
Placebo oral suspension to match EDP-938

Outcome Measures

Primary Outcome Measures

  1. AUC of EDP-938 (Part 1) [Up to 5 days]

  2. Predose concentration of EDP-938 (Part 1) [Up to 5 days]

  3. Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1) [Up to 29 Days]

  4. Daily change from baseline in RSV shedding (Part 2) [Up to 14 Days]

Secondary Outcome Measures

  1. AUC for RSV RNA viral load (Part 1 and Part 2) [Up to 14 Days]

  2. Daily change in RSV shedding (Part 1) [Up to 14 Days]

  3. Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2) [Up to 14 Days]

  4. Time to RSV RNA viral load being undetectable (Part 1 and Part 2) [Up to 14 Days]

  5. AUC of EDP-938 (Part 2) [Up to 5 Days]

  6. Predose concentration of EDP-938 (Part 2) [Up to 5 Days]

  7. Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2) [Up to 29 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Days to 36 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female who is either: born ≥37 weeks of gestation and is age ≥28 days to ≤36 months, defined at the time of randomization, or born <37 weeks of gestation and is age ≥6 months to ≤36 months defined at the time of randomization

  • Subjects diagnosed with RSV infection

  • Subjects with signs of an acute respiratory illness with onset ≤7 days 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

Exclusion Criteria:

  • Use of or anticipated need for intensive monitoring and associated medical care

  • Underlying immune deficiency, eg, 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

  • Receiving an investigational or approved medication that is intended to prevent or treat RSV infection within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Care Miller Children's and Women's Hospital Long Beach California United States 90806
2 University of California Los Angeles (UCLA) Los Angeles California United States 90095
3 UC Davis Sacramento California United States 95817
4 Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
5 University of Florida Health Jacksonville Florida United States 32209
6 Nemours Children's Hospital Orlando Florida United States 32827
7 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611
8 Norton Children's Research Institute Louisville Kentucky United States 40202
9 LSU Health Shreveport Louisiana United States 71101
10 Toledo Hospital Toledo Ohio United States 43606
11 Medical University of South Carolina Charleston South Carolina United States 29425
12 Holston Medical Group Kingsport Tennessee United States 37660
13 Le Bonheur Children's Hospital Memphis Tennessee United States 38103
14 Driscoll Children's Hospital Corpus Christi Texas United States 78411
15 Hospital Interzonal Dr Jose Penna Bahía Blanca Argentina
16 Instituto Medico Rio Cuarto Río Cuarto Argentina
17 Clinica Central S.A Villa Regina Argentina
18 Gold Coast University Hospital Southport Australia
19 Universitätsklinikum Erlangen Erlangen Germany
20 University Hospital Mainz Mainz Germany
21 Asklepios Klinik Sankt Augustin Sankt Augustin Germany
22 Soroka University Medical Center Be'er Sheva Israel
23 Rambam Health Care Haifa Israel 3109601
24 Carmel Medical Center Haifa Israel
25 Hadassah University Hospital Mount Scopu Jerusalem Israel
26 Schneider Children's Medical Center Of Israel Petach Tikva Israel 4920235
27 Nowon Eulji Medical Center, Eulji University Seoul Korea, Republic of 1830
28 Kyung Hee University Hospital Seoul Korea, Republic of 2447
29 Inje University Sanggye Paik Hospital Seoul Korea, Republic of
30 Karla Adriana Espinosa Bautista Mexico City Mexico
31 IESCI Clinical Research Monterrey Mexico
32 PanAmerican Clinical Research Querétaro Mexico
33 SMIQ S de R.L de C.V Querétaro Mexico
34 IN-VIVO Bydgoszcz Bydgoszcz Poland
35 Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi Łódź Poland
36 University of the Witwatersrand Johannesburg South Africa 2093
37 Wits Clinical Research Soweto South Africa 2013
38 Hospital Universitario Arnau de Vilanova Lleida Spain
39 Hospital Clínico San Carlos Madrid Spain
40 Hospital Universitario La Paz Madrid Spain
41 Unidad de Ensayos Clínicos Pediátricos Madrid Spain
42 Hospital Regional Universitario de Málaga Málaga Spain
43 Hospital Clínico Universitario de Santiago Santiago De Compostela Spain
44 Hsinchu Mackay Memorial Hospital Hsinchu Taiwan
45 Chung Shan Medical University Hospital Taichung Taiwan
46 Taipei Mackay Memorial Hospital Taipei Taiwan
47 Alder Hey Children's NHS Foundation Trust Liverpool United Kingdom
48 Sheffield Children's NHS Foundation Trust Sheffield United Kingdom

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:
NCT04816721
Other Study ID Numbers:
  • EDP 938-201
First Posted:
Mar 25, 2021
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enanta Pharmaceuticals
Respiratory Syncytial Virus, RSV, Pediatric study

Study Results

No Results Posted as of May 4, 2022