NCT06094010

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 3 Weeks – 11 Years
• Healthy volunteers: Not accepted

Summary

This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' susceptibility \<12 years with influenza treated with baloxavir marboxil. Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Baloxavir Marboxil	Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms (kg): 80 milligrams (mg); ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 mg/kg).

Timeline

• Start date: 2023-11-22
• Primary completion: 2027-05-11
• Completion: 2027-06-30
• First posted: 2023-10-23
• Last updated: 2026-04-03

Locations

51 sites across 4 countries: United States, Bulgaria, Poland, Spain

Regulatory

• FDA-regulated drug study