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COMPLETED
NCT06774859
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Year - 11 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-10-27

Completion Date

2025-05-08

Last Updated

2026-04-27

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (16)

The First People's Hospital of Changde

Changde, China

Peoples Hospital of Hunan Province

Changsha, China

Chengdu Women's and Children's Central Hospital

Chengdu, China

Chongqing University Jiangjin Hospital

Chongqing, China

Childern's Hospital of Chongqing Medical University

Chongqing, China

Hebei Petro China Central Hospital

Langfang, China

Liaocheng people's Hospital

Liaocheng, China

Linfen Central Hospital

Linfen, China

Liuzhou People's Hospital

Liuchow, China

Ningbo Women and Children's Hospital

Ningbo, China

Sanmenxia Central Hospital

Sanmenxia, China

The Third People's Hospital of Hainan Province

Sanya, China

The Second Affiliated Hospital of Shantou University Medical College

Shantou, China

The First Affiliated Hospital, Shaoyang University

Shaoyang, China

University of Chinese Academy of Sciences Shenzhen Hospital

Shenzhen, China

Xiamen Maternal and Child Health Hospital

Xiamen, China