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

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 27, 2024

Primary Completion Date

May 8, 2025

Study Completion Date

May 8, 2025

Conditions
Influenza
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.

Trial Locations (18)

252000

Liaocheng people's Hospital, Liaocheng

315021

Ningbo Women and Children's Hospital, Ningbo

361001

Xiamen Maternal and Child Health Hospital, Xiamen

402260

Chongqing University Jiangjin Hospital, Chongqing

410007

Peoples Hospital of Hunan Province, Changsha

410008

Hunan Provincial Maternal and Child Health Care Hospital, Changsha

515051

The Second Affiliated Hospital of Shantou University Medical College, Shantou

518107

University of Chinese Academy of Sciences Shenzhen Hospital, Shenzhen

545006

Liuzhou People's Hospital, Liuzhou

572000

The Third People's Hospital of Hainan Province, Sanya

610091

Chengdu Women's and Children's Central Hospital, Chengdu

Unknown

The First People's Hospital of Changde, Changde

Childern's Hospital of Chongqing Medical University, Chongqing

Sanmenxia Central Hospital, Sanmenxia

The First Affiliated Hospital, Shaoyang University, Shaoyang

Yuncheng Central Hospital, Yuncheng

065000

Cnpc Central Hospital, Langfang

041000

Linfen Central Hospital, Linfen

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

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 | Biotech Hunter | Biotech Hunter