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



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 12
Updated:4/3/2019
Start Date:November 20, 2018
End Date:April 2, 2019
Contact:Reference Study ID Number: CP40563 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms

This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil
compared with oseltamivir in a single influenza episode in otherwise healthy pediatric
participants (i.e., 1 to <12 years of age) with influenza-like symptoms.


Inclusion Criteria:

- Aged 1 to < 12 years at randomization (Day 1).

- 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:

- Severe symptoms of influenza virus infection requiring inpatient treatment

- 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
We found this trial at
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sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Anaheim, California 92804
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Bardstown, Kentucky 40004
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Barnwell, South Carolina 29812
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Birmingham, Alabama 35209
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Bridgeton, Missouri 63044
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Charleston, South Carolina 29414
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Charlotte, North Carolina 28210
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Cleveland, Tennessee 37312
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Corpus Christi, Texas 78413
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Dakota Dunes, South Dakota 57049
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Dallas, Texas 75231
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Downey, California 90241
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Fern Creek, Kentucky 40291
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Gainesville, Florida 32607
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Gresham, Oregon 97030
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Harrisburg, Arkansas 72432
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Houston, Texas 77093
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Houston, Texas 77004
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Idaho Falls, Idaho 83404
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1200 Merchants Drive
Jefferson City, Tennessee 37760
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Jonesboro, Arkansas 72401
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Kingsport, Tennessee 37660
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Las Vegas, Nevada 89104
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Los Angeles, California 90004
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10555 West Flagler Street
Miami, Florida 33174
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Minneapolis, Minnesota 55404
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Omaha, Nebraska 68134
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1010 West Chapman Avenue
Ontario, California 91762
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Pensacola, Florida 32504
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5425 West Spring Creek Parkway
Plano, Texas 75093
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Salt Lake City, Utah 84121
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4534 West Gate Boulevard
San Antonio, Texas 78240
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San Diego, California 92102
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South Euclid, Ohio 44121
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Statesville, North Carolina 28625
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750 East Adams Street
Syracuse, New York 13210
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Tampa, Florida 33606
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Tolleson, Arizona 85353
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Tomball, Texas 77375
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1414 Southwest 8th Avenue
Topeka, Kansas 66606
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Tullahoma, Tennessee 37388
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Waxahachie, Texas 75165
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