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NCT03629184 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
A Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
- 20
- Study locations
NCT03629184: Completed Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
NCT03629184 is a Phase 3 study of Influenza that has completed, run by Hoffmann-La Roche. The registered enrollment target is 173 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03629184, a Phase 3 study of Influenza, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to \<12 years of age) with influenza-like symptoms.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) pro
Conditions Studied
Interventions
- DRUG Baloxavir Marboxil
- DRUG Oseltamivir
Study Locations (20)
California
- The Probe Medical Research - Los Angeles
- Orange County Research Institute - Ontario
- Khruz Biotechnology Research Institute - San Diego
Arkansas
- Harrisburg Family Medical Center - Harrisburg
- The Children's Clinic of Jonesboro, P.A. - Jonesboro
North Carolina
- OnSite Clinical Solutions LLC - Charlotte
- Montgomery Medical Research /Frontier Clinical Research - Smithfield
Tennessee
- AFC Urgent Care- Cleveland - Cleveland
- Holston Medical Group - Kingsport
Alabama
- Central Alabama Research; Pediatrics - Birmingham
Florida
- Avanza Medical Research Center - Pensacola
Idaho
- Clinical Research Prime - Idaho Falls
Kansas
- Cotton O'Neil Clinic; Stormont-Vail Hlth Care - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 3 |
What the finished NCT03629184 record still lists
NCT03629184 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Baloxavir Marboxil is the first listed.
NCT03629184 names 20 study sites across 15 states, led by California, Arkansas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03629184 about?
NCT03629184 is a clinical study titled "Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms". This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to \<12 years of age) with influenza-like symptoms.
What is the current status of trial NCT03629184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2018-11-20. Estimated completion is 2019-04-03.
What conditions does trial NCT03629184 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT03629184?
The interventions under investigation include: Baloxavir Marboxil (DRUG), Oseltamivir (DRUG).
Who is sponsoring clinical trial NCT03629184?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03629184 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03629184's enrollment target sits among peer trials
173 87th of 156 higher than 70 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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