Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 1
Updated:4/4/2019
Start Date:January 23, 2019
End Date:September 2, 2020
Contact:Reference Study ID Number: CP40559 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, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in
healthy pediatric participants from birth to <1 year with influenza like symptoms


Inclusion Criteria:

- Age from birth to < 1 year at screening

- Written informed consent for study participation obtained from participant's parents
or legal guardian

- Parent/guardian willing and able to comply with study requirements, in the
investigator's judgment

- Participants with a diagnosis of influenza virus infection confirmed by the presence
of all of the following:

- Fever ≥ 38°C (tympanic temperature) at screening

- At least one respiratory symptom (either cough or coryza)

- The time interval between the onset of symptoms and screening is ≤ 96 hours (the onset
of symptoms is defined as the time when body temperature first exceeded 37.5°C if
known, or the time when the first symptom was noticed by the parent or caregiver)

Exclusion Criteria:

- Hospitalized for complications of influenza or significant comorbidities

- Concurrent infections requiring systemic antiviral therapy at screening

- Require, in the opinion of the investigator, any of the prohibited medication during
the study

- Preterm neonates (born at < 37 weeks gestation) and/or weighing < 2.5 kg at screening

- Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine
within 2 weeks prior to screening

- Immunization with a live/attenuated influenza vaccine during the 2 weeks prior to
screening

- 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 transplant

- Known allergy to study drug (i.e., baloxavir marboxil) or to acetaminophen

- 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
17
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Bardstown, Kentucky 40004
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Charleston, South Carolina 29414
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Dallas, Texas 75231
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Houston, Texas 77093
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Idaho Falls, Idaho 83404
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Jonesboro, Arkansas 72401
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Lincoln, NE
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Minneapolis, Minnesota 55404
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Pensacola, Florida 32504
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4534 West Gate Boulevard
San Antonio, Texas 78240
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San Jose,
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750 East Adams Street
Syracuse, New York 13210
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Tampa, Florida 33606
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Tomball, Texas 77375
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Tomball, TX
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