Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
Public ClinicalTrials.gov record NCT03653364. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms
Study identification
- NCT ID
- NCT03653364
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Hoffmann-La Roche
- Industry
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Interventions
- Baloxavir Marboxil Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 1 Year
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 22, 2019
- Primary completion
- Apr 2, 2023
- Completion
- Apr 2, 2023
- Last update posted
- May 16, 2024
2019 – 2023
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | — |
| Usf Health | Tampa | Florida | 33606 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago;Division of Infectious Disease | Chicago | Illinois | 60611 | — |
| Kentucky Pediatric Research Center | Bardstown | Kentucky | 40004 | — |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75218 | — |
| Mercury Clinical Research | Houston | Texas | 77036-3316 | — |
| Tekton Research | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03653364, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2024 · Synced Jun 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03653364 live on ClinicalTrials.gov.