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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 23, 2019

Primary Completion Date

April 3, 2023

Study Completion Date

April 3, 2023

Conditions

Influenza

Interventions

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.

Trial Locations (27)

1401

GAMA; Clinical Research, Germiston

1619

Peermed Clinical Trial Centre, Kempton Park

3400

MHAT Stamen Iliev AD, Montana

7002

SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and Phtisiatrics, Rousse

10108

ICIMED Instituto de Investigación en Ciencias Médicas, San José

15706

Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría, Santiago de Compostela

28041

Hospital Universitario 12 de Octubre; Servicio de Pediatria, Madrid

33520

TAYS Lastenklinikka; Lasten lääketutkimuskeskus Peetu, Tampere

33606

Usf Health, Tampa

40004

Kentucky Pediatric Research Center, Bardstown

60611

Ann & Robert H. Lurie Children's Hospital of Chicago;Division of Infectious Disease, Chicago

72401

The Children's Clinic of Jonesboro, P.A., Jonesboro

75218

Oak Cliff Research Company, LLC, Dallas

78229

Tekton Research, San Antonio

83404

Clinical Research Prime, Idaho Falls

111123

The scientific-research institute of epidemiology; Infectious clinical hospital ?2 of Moscow H.D., Moskva

4931807

Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic, Petah Tikva

77036-3316

Mercury Clinical Research, Houston

21-010

NZOZ Salmed, ??czna

05-092

Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym, ?omianki

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny; Oddzia? Pediatrii, Chorób Infekcyjnych i Hepatologii, Bydgoszcz

85-048

IN VIVO Sp. z o.o., Bydgoszcz

85-079

NZOZ Vitamed, Bydgoszcz

0001

Global Clinical Trials; Clinical Trials, Gauteng

0699

Metropolitan Clinical Research Institute, Polokwane

Pholosho Netcare; Netcare Hospital, Polokwane

0152

Setshaba Research Centre; Clinical Research, Pretoria

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY