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)

Use our guide to learn which trials are right for you!

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
sites
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Bardstown, Kentucky 40004
?
mi
from
Bardstown, KY
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Houston, Texas 77093
?
mi
from
Houston, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
4534 West Gate Boulevard
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Jose,
Click here to add this to my saved trials
750 East Adams Street
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tampa, Florida 33606
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tomball, Texas 77375
?
mi
from
Tomball, TX
Click here to add this to my saved trials