NCT03629184

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms

A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 1 Year – 11 Years
• Healthy volunteers: Not accepted

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

• Influenza

Interventions

Type	Name	Description
DRUG	Baloxavir Marboxil	Baloxavir marboxil will be administered as oral suspension in a single dose on Day 1. Oseltamivir matching placebo will also be administered as oral suspension twice daily (BID) for 5 days.
DRUG	Oseltamivir	Oseltamivir will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive baloxavir marboxil matching placebo as oral suspension, single dose on Day 1.

Timeline

• Start date: 2018-11-20
• Primary completion: 2019-04-03
• Completion: 2019-04-03
• First posted: 2018-08-14
• Last updated: 2020-04-29
• Results posted: 2020-04-29

Locations

37 sites across 7 countries: United States, Costa Rica, Israel, Mexico, Poland, Russia, Spain

Regulatory

• FDA-regulated drug study