Trial record 1 of 39 for:
Enanta
A Study to Evaluate EDP 938 Regimens in Children With RSV (RSVPEDs)
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| ClinicalTrials.gov Identifier: NCT04816721 |
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Recruitment Status :
Recruiting
First Posted : March 25, 2021
Last Update Posted : March 20, 2023
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Sponsor:
Enanta Pharmaceuticals, Inc
Information provided by (Responsible Party):
Enanta Pharmaceuticals, Inc
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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 |
|---|---|---|
| Respiratory Syncytial Virus (RSV) | Drug: EDP-938 Drug: Placebo | Phase 2 |
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 : | 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 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) |
| Actual Study Start Date : | April 26, 2022 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Viral Infections
| Arm | Intervention/treatment |
|---|---|
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Experimental: EDP-938
EDP-938, oral suspension, once daily for 5 days
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Drug: EDP-938
Oral suspension |
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Placebo Comparator: Placebo
Matching placebo, orally, once daily for 5 days
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Drug: Placebo
Placebo oral suspension to match EDP-938 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
- Time to discharge for hospitalized subjects (Part 2) [ Time Frame: Up to 29 Days ]
- 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) [ Time Frame: Up to 29 Days ]
- Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement [ Time Frame: Up to 29 Days ]
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| Ages Eligible for Study: | 28 Days to 36 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 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 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
- 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. RSV-specific monoclonal antibodies are not prohibited in Part 1.
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
| Contact: Enanta Pharmaceuticals, Inc | (617) 607-0800 | gdelarosa@enanta.com |
Locations
Show 72 study locations
Sponsors and Collaborators
Enanta Pharmaceuticals, Inc
Investigators
| Study Director: | Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc |
| Responsible Party: | Enanta Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT04816721 |
| Other Study ID Numbers: |
EDP 938-201 |
| First Posted: | March 25, 2021 Key Record Dates |
| Last Update Posted: | March 20, 2023 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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, Inc:
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Respiratory Syncytial Virus, RSV, Pediatric study |