Trials / Completed
CompletedNCT04816721
A Study to Evaluate EDP 938 Regimens in Children With RSV
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (actual)
- Sponsor
- Enanta Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 28 Days – 36 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EDP-938 | Oral suspension |
| DRUG | Placebo | Placebo oral suspension to match EDP-938 |
Timeline
- Start date
- 2022-04-26
- Primary completion
- 2024-08-19
- Completion
- 2024-08-19
- First posted
- 2021-03-25
- Last updated
- 2025-07-28
- Results posted
- 2025-07-08
Locations
78 sites across 15 countries: United States, Argentina, Australia, Brazil, Germany, Israel, Mexico, New Zealand, Poland, Romania, South Africa, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04816721. Inclusion in this directory is not an endorsement.