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

PHASE3CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

November 20, 2018

Primary Completion Date

April 3, 2019

Study Completion Date

April 3, 2019

Conditions
Influenza
Interventions
DRUG

Baloxavir Marboxil

"Baloxavir marboxil will be administered as oral suspension in a single dose on Day 1.~Oseltamivir matching placebo will also be administered as oral suspension twice daily (BID) for 5 days."

DRUG

Oseltamivir

Oseltamivir will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive baloxavir marboxil matching placebo as oral suspension, single dose on Day 1.

Trial Locations (37)

10108

ICIMED Instituto de Investigación en Ciencias Médicas, San José

15478

Montgomery Medical Research /Frontier Clinical Research, Smithfield

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

28203

OnSite Clinical Solutions LLC, Charlotte

29414

Coastal Pediatric Research, Charleston

32503

Avanza Medical Research Center, Pensacola

35209

Central Alabama Research; Pediatrics, Birmingham

37312

AFC Urgent Care- Cleveland, Cleveland

37660

Holston Medical Group, Kingsport

40004

Kentucky Pediatric Research Center, Bardstown

45414

Ohio Pediatric Research Association, Dayton

63044

Spiegel, Craig, Bridgeton

64710

Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey, Monterrey, N.L

66606

Cotton O'Neil Clinic; Stormont-Vail Hlth Care, Topeka

68134

Meridian Clinical Research, Llc, Omaha

72401

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

72432

Harrisburg Family Medical Center, Harrisburg

75165

ClinPoint Trials, Waxahachie

75243

Oak Cliff Research Company, LLC, Dallas

77004

HD Research Corp, Houston

77375

DM Clinical Research, Tomball

78240

Tekton Research, San Antonio

83404

Clinical Research Prime, Idaho Falls

84121

FirstMed East (J Lewis Research), Salt Lake City

84123

Advanced Clinical Research - Jordan Ridge Family Medicine, Salt Lake City

89104

Machuca Family Medicine, Las Vegas

90004

The Probe Medical Research, Los Angeles

91762

Orange County Research Institute, Ontario

92102

Khruz Biotechnology Research Institute, San Diego

443100

MC Gepatolog, Samara

4931807

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

77036-3316

Mercury Clinical Research, Houston

85-030

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

85-079

NZOZ Vitamed, Bydgoszcz

39-200

Prywatny Gabinet Lekarski, Dębica

41-103

NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska, Siemianowice Śląskie

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03629184 - Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms | Biotech Hunter | Biotech Hunter