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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03629184
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : November 30, 2018
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Baloxavir Marboxil Drug: Oseltamivir Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 13, 2018
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : June 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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
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.

Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 29 ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Secondary Outcome Measures :
  1. Plasma Concentrations of Baloxavir Marboxil and S-033447 [ Time Frame: Day 2 and Day 4 ]
  2. Area Under the Concentration to Time Curve from Time 0 to Infinity (AUC0-inf) of baloxavir marboxil and S-033447 [ Time Frame: Up to Day 10 ]
  3. Maximum Plasma Concentration (Cmax) of baloxavir marboxil and S-033447 [ Time Frame: Up to Day 10 ]
  4. Time to Maximum Plasma Concentration (Tmax) of baloxavir marboxil and S-033447 [ Time Frame: Up to Day 10 ]
  5. Apparent Half-Life (T1/2) of baloxavir marboxil and S-033447 [ Time Frame: Up to Day 10 ]
  6. Time to Alleviation of Influenza Signs and Symptoms [ Time Frame: Up to Day 15 ]

    Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met and remain so for at least 21.5 hours:

    • A score of 0 (no problem) or 1 (minor problem) for cough and nasal symptoms (items 14 and 15 of the Canadian Acute Respiratory Illness and Flu Scale [CARIFS])
    • A "yes" response to the following question on the CARIFS: "Since the last assessment has the subject been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?"
    • First return to afebrile state (tympanic temperature ≤37.2 degree Celsius [°C])

  7. Duration of Fever [ Time Frame: Up to Day 15 ]
    Length of time taken by participants to return to afebrile state [tympanic temperature ≤ 37.2°C] and remaining so for at least 21.5 hours.

  8. Duration of Symptoms [ Time Frame: Up to Day 15 ]
    The clinical efficacy of baloxavir marboxil is evaluated by duration of symptoms i.e., alleviation of all symptoms as defined by a score of 0 [no problem] or 1 [minor problem] and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire).

  9. Time to Return to Normal Health and Activity [ Time Frame: Up to Day 15 ]
  10. Frequency of Influenza-Related Complications [ Time Frame: Up to Day 29 ]
    The influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.

  11. Percentage of Participants Requiring Antibiotics [ Time Frame: Up to Day 29 ]
  12. Time to Cessation of Viral Shedding by Virus Titer and by RT-PCR [ Time Frame: Day 1 - Day 29 ]
  13. Change from Baseline in Influenza Virus Titer and in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29 [ Time Frame: Baseline, Day 2, 4, 6, 10, 15, 29 ]
  14. Percentage of Participants with Positive Influenza Virus Titer and Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29 [ Time Frame: Day 2, 4, 6, 10, 15, 29 ]
  15. Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR) [ Time Frame: Day 1 - Day 29 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03629184

Contact: Reference Study ID Number: CP40563 888-662-6728 (U.S. and Canada)

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United States, Alabama
Central Alabama Research; Pediatrics Not yet recruiting
Birmingham, Alabama, United States, 35209
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
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Alliance Urgent Care-Tolleson Not yet recruiting
Tolleson, Arizona, United States, 85353
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Harrisburg Family Medical Center Not yet recruiting
Harrisburg, Arkansas, United States, 72432
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Jonesboro, Arkansas, United States, 72401
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Emmaus Research Center, Inc. Recruiting
Anaheim, California, United States, 92804
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Downey, California, United States, 90241
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San Diego, California, United States, 92102
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Aurora, Colorado, United States, 80045
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Washington, District of Columbia, United States, 20007
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DeLand, Florida, United States, 32720
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Gainesville, Florida, United States, 32607
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Miami, Florida, United States, 33174
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Pensacola, Florida, United States, 32503
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Tampa, Florida, United States, 33606
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Clinical Research Prime Not yet recruiting
Idaho Falls, Idaho, United States, 83404
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Ann & Robert H. Lurie Children's Hospital of Chicago;Division of Infectious Disease Not yet recruiting
Chicago, Illinois, United States, 60611
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Cotton O'Neil Clinic; Stormont-Vail Hlth Care Recruiting
Topeka, Kansas, United States, 66606
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Kentucky Pediatric Research Center Not yet recruiting
Bardstown, Kentucky, United States, 40004
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Fern Creek, Kentucky, United States, 40291
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Children's Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55404
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Spiegel, Craig Recruiting
Bridgeton, Missouri, United States, 63044
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Midwest Childrens Health Research Institute Recruiting
Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68134
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Machuca Family Medicine Recruiting
Las Vegas, Nevada, United States, 89104
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Syracuse, New York, United States, 13210
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Statesville, North Carolina, United States, 28625
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Ohio Pediatric Research Association Recruiting
Dayton, Ohio, United States, 45414
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South Euclid, Ohio, United States, 44121
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Cyn3rgy Research Recruiting
Gresham, Oregon, United States, 97030
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Rainbow Research Not yet recruiting
Barnwell, South Carolina, United States, 29812
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Charleston, South Carolina, United States, 29414
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Dakota Dunes, South Dakota, United States, 57049
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Cleveland, Tennessee, United States, 37312
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Jefferson City, Tennessee, United States, 37760
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Kingsport, Tennessee, United States, 37660
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Tullahoma, Tennessee, United States, 37388
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Corpus Christi, Texas, United States, 78413
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77004
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Houston, Texas, United States, 77036-3316
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Houston, Texas, United States, 77036-3316
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Houston, Texas, United States, 77036-3316
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Plano, Texas, United States, 75093
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Salt Lake City, Utah, United States, 84123
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Tacoma, Washington, United States, 98405
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Buenos Aires, Argentina, 1425
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Mendoza, Mendoza City, Argentina, M5500CCG
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Quilmes, Argentina, 1878
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San Miguel de Tucuman, Argentina, 4000
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ICIMED Instituto de Investigación en Ciencias Médicas Not yet recruiting
San Jose, Costa Rica, 10108
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Petach Tikva, Israel, 4931807
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Ciudad de México, Mexico CITY (federal District), Mexico, 4530
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Mexico City, Mexico, 06720
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Panama, Panama, 0816-06812
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Caguas, Puerto Rico, 00725
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The scientific-research institute of epidemiology; Infectious clinical hospital №2 of Moscow H.D. Not yet recruiting
Moskva, Moskovskaja Oblast, Russian Federation, 105275
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Saint Petersburg, Russian Federation, 197022
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Samara, Russian Federation, 443100
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Smolensk, Russian Federation, 214019
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Cosmo CITY, South Africa, 2188
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Germiston, South Africa, 1401
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Kempton Park, South Africa, 1619
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Pretoria, South Africa, 0152
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Soweto, South Africa, 1818
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Worcester, South Africa, 6850
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría Not yet recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
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Madrid, Spain, 28007
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Madrid, Spain, 28041
Sponsors and Collaborators
Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT03629184     History of Changes
Other Study ID Numbers: CP40563
2018-002169-21 ( EudraCT Number )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action