Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
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).
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