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

Phase 3 Completed 173 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2018-11-20
Primary completion: 2019-04-03
Completion: 2019-04-03

Outcome

Met primary endpoint

release “The miniSTONE-2 study met its primary endpoint of safety” roche.com ↗

Publications

Baker J, Block SL, Matharu B, Burleigh Macutkiewicz L, Wildum S, Dimonaco S, Collinson N, Clinch B, Piedra PA. Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2). Pediatr Infect Dis J. 2020 Aug;39(8):700-705. doi: 10.1097/INF.0000000000002747.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baloxavir Marboxil	Unknown	—	Oral
Comparator	Oseltamivir	Small molecule	—	Oral