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NCT03684044 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
A Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 363
- Enrollment target
- 20
- Study locations
NCT03684044 is a Phase 3 study of Influenza that has completed, run by Hoffmann-La Roche. The registered enrollment target is 363 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT03684044, a Phase 3 study of Influenza, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 363 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Baloxavir Marboxil
Study Locations (20)
Other
- Instituto Medico Platense - La Plata
- Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery - Brussels
- Cliniques Universitaires Saint-Luc; Hematology - Brussels
- UZ Leuven - Leuven
Illinois
- University of Chicago; Oncology Dept - Chicago
- NorthShore University HealthSystem - Evanston
California
- Torrance Memorial Medical Center - Torrance
Colorado
- Denver Health Medical Center - Denver
Georgia
- Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy - Decatur
Louisiana
- Barnum Medical Research, Inc. - Natchitoches
Michigan
- Detroit Receiving Hospital - Detroit
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03684044
The ClinicalTrials.gov registry entry for NCT03684044 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 363 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% 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 Placebo is the first listed.
NCT03684044 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT03684044 about?
NCT03684044 is a clinical study titled "Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza". This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients wi...
What is the current status of trial NCT03684044?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2019-01-08. Estimated completion is 2020-03-16.
What conditions does trial NCT03684044 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT03684044?
The interventions under investigation include: Placebo (OTHER), Baloxavir Marboxil (DRUG).
Who is sponsoring clinical trial NCT03684044?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03684044 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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