At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
Baloxavir Marboxildrug
Likely dose
Baloxavir Marboxil 2 milligramsfrom 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.
A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms
In Brief
A Phase 3 clinical trial evaluating Baloxavir Marboxil for Influenza. Completed, enrolled 49 participants across 27 sites in 9 countries.
Detailed Summary
This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to \<1 year with influenza like symptoms
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBulgaria, Costa Rica, Finland, Israel, Poland, Russia, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartJan 2019
Primary CompletionApr 2023
TodayJul 2026
First PostedAug 31, 2018
Enrollment StartJan 23, 2019
Primary CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.8 years ago
Interventions
Baloxavir Marboxildrug
Participants will receive single oral dose of baloxavir marboxil on Day 1 based on body weight and age. Participants aged ≥ 3 months to \<12 months old received baloxavir marboxil, 2 milligrams per kilograms (mg/kg). Participants from birth to \< 4 weeks old and ≥ 4 weeks to \< 3 months old received baloxavir marboxil, 1 mg/kg.