Back to resultsStudy to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baloxavir Marboxil
Oseltamivir
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility Criteria
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
Sites / Locations
- Central Alabama Research; Pediatrics
- Harrisburg Family Medical Center
- The Children's Clinic of Jonesboro, P.A.
- The Probe Medical Research
- Orange County Research Institute
- Khruz Biotechnology Research Institute
- Avanza Medical Research Center
- Clinical Research Prime
- Cotton O'Neil Clinic; Stormont-Vail Hlth Care
- Kentucky Pediatric Research Center
- Spiegel, Craig
- Meridian Clinical Research, Llc
- Machuca Family Medicine
- OnSite Clinical Solutions LLC
- Montgomery Medical Research /Frontier Clinical Research
- Ohio Pediatric Research Association
- Coastal Pediatric Research
- AFC Urgent Care- Cleveland
- Holston Medical Group
- Oak Cliff Research Company, LLC
- HD Research Corp
- Mercury Clinical Research
- Tekton Research
- DM Clinical Research
- ClinPoint Trials
- FirstMed East (J Lewis Research)
- Advanced Clinical Research - Jordan Ridge Family Medicine
- ICIMED Instituto de Investigación en Ciencias Médicas
- Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
- Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
- Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
- NZOZ Vitamed
- Prywatny Gabinet Lekarski
- NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska
- MC Gepatolog
- Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
- Hospital Universitario 12 de Octubre; Servicio de Pediatria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Baloxavir Marboxil
Oseltamivir
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Plasma Concentrations of S-033447 - Sparse PK Population
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm.
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Plasma Concentrations of S-033447 - Extensive PK Population
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Time to Alleviation of Influenza Signs and Symptoms
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])
Duration of Fever
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.
Duration of Symptoms
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.
Time to Return to Normal Health and Activity
Time to Return to Normal health and activity' is identified by a 'Yes' response to the following question on the CARIFS: "Since the last assessment has the patient 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?"
Frequency of Influenza-Related Complications
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Percentage of Participants With Influenza-Related Complications
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Percentage of Participants Requiring Antibiotics
Time to Cessation of Viral Shedding by Virus Titer
Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of any study treatment and first time when the influenza virus titer is below the limit of detection.
Time to Cessation of Viral Shedding by RT-PCR
Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of any study treatment and first time when the virus RNA by RT-PCR is below the limit of detection.
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Influenza virus titer (log10TCID50/ML) is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10TCID50/mL). A lower value indicates lower viral titer.
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Area Under the Curve in Virus Titer
Area under the curve (AUC) in virus titer was calculated using the trapezoidal method.
Area Under the Curve in the Amount of Virus RNA (RT-PCR)
AUC in virus RNA (RT-PCR) is defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 10. AUC is calculated using the trapezoidal method similar to AUC in virus titer.
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Maximum Plasma Concentration (Cmax) of S-033447
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time to Maximum Plasma Concentration (Tmax) of S-033447
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Plasma Concentrations of Baloxavir Marboxil by Dosage
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Plasma Concentrations of S-033447 by Dosage
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03629184
Brief Title
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baloxavir Marboxil
Arm Type
Experimental
Arm Description
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.
Arm Title
Oseltamivir
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Baloxavir Marboxil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Intervention Description
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 Measure Information:
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Day 29
Secondary Outcome Measure Information:
Title
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
Description
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Time Frame
Days 1 (Post-Dose), 2, 4, 6 and 10
Title
Plasma Concentrations of S-033447 - Sparse PK Population
Description
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm.
Time Frame
Days 1 (Post-Dose), 2, 4, 6 and 10
Title
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Description
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Time Frame
Days 1 (Post-Dose), 2, 4, 6 and 10
Title
Plasma Concentrations of S-033447 - Extensive PK Population
Description
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Time Frame
Days 1 (Post-Dose), 2, 4, 6 and 10
Title
Time to Alleviation of Influenza Signs and Symptoms
Description
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])
Time Frame
Up to Day 15
Title
Duration of Fever
Description
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.
Time Frame
Up to Day 15
Title
Duration of Symptoms
Description
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.
Time Frame
Up to Day 15
Title
Time to Return to Normal Health and Activity
Description
Time to Return to Normal health and activity' is identified by a 'Yes' response to the following question on the CARIFS: "Since the last assessment has the patient 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?"
Time Frame
Up to Day 15
Title
Frequency of Influenza-Related Complications
Description
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Time Frame
Up to Day 29
Title
Percentage of Participants With Influenza-Related Complications
Description
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Time Frame
Up to Day 29
Title
Percentage of Participants Requiring Antibiotics
Time Frame
Up to Day 29
Title
Time to Cessation of Viral Shedding by Virus Titer
Description
Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of any study treatment and first time when the influenza virus titer is below the limit of detection.
Time Frame
Day 1 - Day 29
Title
Time to Cessation of Viral Shedding by RT-PCR
Description
Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of any study treatment and first time when the virus RNA by RT-PCR is below the limit of detection.
Time Frame
Day 1 - Day 29
Title
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Description
Influenza virus titer (log10TCID50/ML) is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10TCID50/mL). A lower value indicates lower viral titer.
Time Frame
Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Title
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Description
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Time Frame
Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Title
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Time Frame
Baseline, Day 2, 3 (optional), 4, 6, 10
Title
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Time Frame
Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Title
Area Under the Curve in Virus Titer
Description
Area under the curve (AUC) in virus titer was calculated using the trapezoidal method.
Time Frame
Day 1 - Day 29
Title
Area Under the Curve in the Amount of Virus RNA (RT-PCR)
Description
AUC in virus RNA (RT-PCR) is defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 10. AUC is calculated using the trapezoidal method similar to AUC in virus titer.
Time Frame
Day 1 - Day 10
Title
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
Up to Day 10
Title
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
Up to Day 10
Title
Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
Up to Day 10
Title
Maximum Plasma Concentration (Cmax) of S-033447
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
Up to Day 10
Title
Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
Up to Day 10
Title
Time to Maximum Plasma Concentration (Tmax) of S-033447
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
Up to Day 10
Title
Plasma Concentrations of Baloxavir Marboxil by Dosage
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
24, 72, 96 and 240 hours post-dose
Title
Plasma Concentrations of S-033447 by Dosage
Description
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.
Time Frame
24, 72, 96 and 240 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Central Alabama Research; Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Harrisburg Family Medical Center
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
The Children's Clinic of Jonesboro, P.A.
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
The Probe Medical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90004
Country
United States
Facility Name
Orange County Research Institute
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Khruz Biotechnology Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Cotton O'Neil Clinic; Stormont-Vail Hlth Care
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Kentucky Pediatric Research Center
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Spiegel, Craig
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Meridian Clinical Research, Llc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Machuca Family Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
OnSite Clinical Solutions LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Montgomery Medical Research /Frontier Clinical Research
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
15478
Country
United States
Facility Name
Ohio Pediatric Research Association
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
AFC Urgent Care- Cleveland
City
Cleveland
State/Province
Tennessee
ZIP/Postal Code
37312
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Oak Cliff Research Company, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
HD Research Corp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Mercury Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77036-3316
Country
United States
Facility Name
Tekton Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Facility Name
FirstMed East (J Lewis Research)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Advanced Clinical Research - Jordan Ridge Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San Jose
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
City
Petach Tikva
ZIP/Postal Code
4931807
Country
Israel
Facility Name
Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
City
Monterrey, N.L
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Prywatny Gabinet Lekarski
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska
City
Siemianowice Śląskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
MC Gepatolog
City
Samara
ZIP/Postal Code
443100
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Pediatria
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32516282
Citation
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.
Results Reference
derived
Learn more about this trial
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
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