Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
NCT ID: NCT03629184
Last Updated: 2020-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
2018-11-20
2019-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Baloxavir Marboxil
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
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.
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
* Participant able to comply with study requirements, depending on the patient's level of understanding
* Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
* Fever ≥ 38 degree celsius (tympanic temperature) at screening
* At least one respiratory symptom (either cough or nasal congestion)
* The time interval between the onset of symptoms and screening is ≤ 48 hours
Exclusion Criteria
* Concurrent infections requiring systemic antiviral therapy at screening
* Require, in the opinion of the investigator, any of the prohibited medication during the study
* Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
* Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
* Concomitant treatment with steroids or other immuno-suppressant therapy
* Known HIV infection or other immunosuppressive disorder
* Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure.
* Active cancer at any site
* History of organ transplantation
* Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
* Females with child-bearing potential
* Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
1 Year
11 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Central Alabama Research; Pediatrics
Birmingham, Alabama, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
The Probe Medical Research
Los Angeles, California, United States
Orange County Research Institute
Ontario, California, United States
Khruz Biotechnology Research Institute
San Diego, California, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Cotton O'Neil Clinic; Stormont-Vail Hlth Care
Topeka, Kansas, United States
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States
Spiegel, Craig
Bridgeton, Missouri, United States
Meridian Clinical Research, Llc
Omaha, Nebraska, United States
Machuca Family Medicine
Las Vegas, Nevada, United States
OnSite Clinical Solutions LLC
Charlotte, North Carolina, United States
Montgomery Medical Research /Frontier Clinical Research
Smithfield, North Carolina, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
AFC Urgent Care- Cleveland
Cleveland, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Oak Cliff Research Company, LLC
Dallas, Texas, United States
HD Research Corp
Houston, Texas, United States
Mercury Clinical Research
Houston, Texas, United States
Tekton Research
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
FirstMed East (J Lewis Research)
Salt Lake City, Utah, United States
Advanced Clinical Research - Jordan Ridge Family Medicine
Salt Lake City, Utah, United States
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
Petah Tikva, , Israel
Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
Monterrey, N.L, , Mexico
Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
Bydgoszcz, , Poland
NZOZ Vitamed
Bydgoszcz, , Poland
Prywatny Gabinet Lekarski
Dębica, , Poland
NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska
Siemianowice Śląskie, , Poland
MC Gepatolog
Samara, , Russia
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario 12 de Octubre; Servicio de Pediatria
Madrid, , Spain
Countries
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References
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Baker J, Block SL, Matharu B, Burleigh Macutkiewicz L, Wildum S, Dimonaco S, Collinson N, Clinch B, Piedra PA. Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2). Pediatr Infect Dis J. 2020 Aug;39(8):700-705. doi: 10.1097/INF.0000000000002747.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002169-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP40563
Identifier Type: -
Identifier Source: org_study_id
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