NCT06774859

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms

A Phase III, Randomized, Open-Label, Active-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Patients 1 to <12 Years of Age With Influenza Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 1 Year – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to \< 12 years with influenza symptoms.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Baloxavir Marboxil	Baloxavir marboxil will be administered as oral suspension: 2 milligrams per kilograms (mg/kg) (if weight \< 20 kg), 40 mg (if weight ≥ 20 kg to \< 80 kg), or 80 mg (if weight ≥ 80 kg).
DRUG	Oseltamivir	Oseltamivir will be administered as oral capsule: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≥ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days.

Timeline

• Start date: 2024-10-27
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2025-01-14
• Last updated: 2025-05-18

Locations

18 sites across 1 country: China