NCT03653364

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Baloxavir Marboxil	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.

Timeline

• Start date: 2019-01-23
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2018-08-31
• Last updated: 2024-05-17
• Results posted: 2024-05-17

Locations

27 sites across 9 countries: United States, Bulgaria, Costa Rica, Finland, Israel, Poland, Russia, South Africa, Spain

Regulatory

• FDA-regulated drug study