Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03629184
The ClinicalTrials.gov registry entry for NCT03629184 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
-
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
ACTIVE NOT RECRUITING · Phase 3
-
Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
COMPLETED · Phase 3
-
Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
COMPLETED · Phase 3
-
Study of Quadrivalent Influenza Vaccine Among Children
COMPLETED · Phase 3
-
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.