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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816721
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE March 23, 2021
First Posted Date  ICMJE March 25, 2021
Last Update Posted Date October 12, 2022
Actual Study Start Date  ICMJE April 26, 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • AUC of EDP-938 (Part 1) [ Time Frame: Up to 5 days ]
  • Predose concentration of EDP-938 (Part 1) [ Time Frame: Up to 5 days ]
  • Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1) [ Time Frame: Up to 29 Days ]
  • Daily change from baseline in RSV shedding (Part 2) [ Time Frame: Up to 14 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • AUC for RSV RNA viral load (Part 1 and Part 2) [ Time Frame: Up to 14 Days ]
  • Daily change in RSV shedding (Part 1) [ Time Frame: Up to 14 Days ]
  • Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2) [ Time Frame: Up to 14 Days ]
  • Time to RSV RNA viral load being undetectable (Part 1 and Part 2) [ Time Frame: Up to 14 Days ]
  • AUC of EDP-938 (Part 2) [ Time Frame: Up to 5 Days ]
  • Predose concentration of EDP-938 (Part 2) [ Time Frame: Up to 5 Days ]
  • Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2) [ Time Frame: Up to 29 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate EDP 938 Regimens in Children With RSV
Official Title  ICMJE 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)
Brief Summary A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Syncytial Virus (RSV)
Intervention  ICMJE
  • Drug: EDP-938
    Oral suspension
  • Drug: Placebo
    Placebo oral suspension to match EDP-938
Study Arms  ICMJE
  • Experimental: EDP-938
    EDP-938, oral suspension, once daily for 5 days
    Intervention: Drug: EDP-938
  • Placebo Comparator: Placebo
    Matching placebo, orally, once daily for 5 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2021)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Days to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Enanta Pharmaceuticals, Inc (617) 607-0800 gdelarosa@enanta.com
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Germany,   Israel,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Romania,   South Africa,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04816721
Other Study ID Numbers  ICMJE EDP 938-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Enanta Pharmaceuticals, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Enanta Pharmaceuticals, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
PRS Account Enanta Pharmaceuticals, Inc
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP