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A Study to Evaluate EDP 938 Regimens in Infants With RSV (RSVPEDs)

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ClinicalTrials.gov Identifier: NCT04816721
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus (RSV) Drug: EDP-938 Drug: Placebo 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 24 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 24 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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




Primary Outcome Measures :
  1. AUC of EDP-938 (Part 1) [ Time Frame: Up to 5 days ]
  2. Predose concentration of EDP-938 (Part 1) [ Time Frame: Up to 5 days ]
  3. Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1) [ Time Frame: Up to 29 Days ]
  4. Daily change from baseline in RSV shedding (Part 2) [ Time Frame: Up to 14 Days ]

Secondary Outcome Measures :
  1. AUC for RSV RNA viral load (Part 1 and Part 2) [ Time Frame: Up to 14 Days ]
  2. Daily change in RSV shedding (Part 1) [ Time Frame: Up to 14 Days ]
  3. Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2) [ Time Frame: Up to 14 Days ]
  4. Time to RSV RNA viral load being undetectable (Part 1 and Part 2) [ Time Frame: Up to 14 Days ]
  5. AUC of EDP-938 (Part 2) [ Time Frame: Up to 5 Days ]
  6. Predose concentration of EDP-938 (Part 2) [ Time Frame: Up to 5 Days ]
  7. Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2) [ Time Frame: Up to 29 Days ]


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female who is either: born ≥37 weeks of gestation and is age ≥28 days to ≤24 months, defined at the time of randomization, or born <37 weeks of gestation and is age ≥6 months to ≤24 months defined at the time of randomization
  • Subjects diagnosed with RSV infection
  • Subjects with signs of an acute respiratory illness with onset ≤72 hours (for hospitalized subjects) and ≤48 hours (non hospitalized subjects) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816721


Contacts
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Contact: Enanta Pharmaceuticals, Inc 857 760 0548 gdelarosa@enanta.com

Locations
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United States, Florida
Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
United States, Texas
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04816721    
Other Study ID Numbers: EDP 938-201
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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