Trials / Completed
CompletedNCT03684044
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 III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 363 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baloxavir Marboxil | Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. |
| OTHER | Placebo | Participants will receive matching placebo on Days 1, 4 and 7. |
Timeline
- Start date
- 2019-01-08
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
- First posted
- 2018-09-25
- Last updated
- 2021-01-06
- Results posted
- 2020-11-30
Locations
170 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Estonia, Finland, France, Germany, Hong Kong, Israel, Japan, Mexico, Netherlands, New Zealand, Peru, Romania, Serbia, Singapore, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03684044. Inclusion in this directory is not an endorsement.