CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 363 enrolled
Drug / intervention
Baloxavir Marboxil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03684044
NCT03684044Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Sep 25, 2018·Updated Jan 6, 2021

In Brief

A Phase 3 clinical trial evaluating Baloxavir Marboxil and Placebo for Influenza. Completed, enrolled 363 participants across 170 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 25, 2018
Enrollment StartJan 8, 2019
Primary CompletionMar 16, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.8 years ago

Interventions

Baloxavir Marboxildrug

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.

Placeboother

Participants will receive matching placebo on Days 1, 4 and 7.