InfluenzaPhase 3NCT03629184
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
A Phase 3 study testing Baloxavir Marboxil and Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 37 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Influenza
- What is being tested?
- Baloxavir Marboxil and Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 20 Nov 2018to 3 Apr 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States27 sites
Kentucky Pediatric Research Center
Bardstown, Kentucky, 40004
Central Alabama Research; Pediatrics
Birmingham, Alabama, 35209
Spiegel, Craig
Bridgeton, Missouri, 63044
Coastal Pediatric Research
Charleston, South Carolina, 29414
OnSite Clinical Solutions LLC
Charlotte, North Carolina, 28203
AFC Urgent Care- Cleveland
Cleveland, Tennessee, 37312
Oak Cliff Research Company, LLC
Dallas, Texas, 75243
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432
HD Research Corp
Houston, Texas, 77004
Mercury Clinical Research
Houston, Texas, 77036-3316
Clinical Research Prime
Idaho Falls, Idaho, 83404
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Holston Medical Group
Kingsport, Tennessee, 37660
Machuca Family Medicine
Las Vegas, Nevada, 89104
The Probe Medical Research
Los Angeles, California, 90004
Meridian Clinical Research, Llc
Omaha, Nebraska, 68134
Orange County Research Institute
Ontario, California, 91762
Avanza Medical Research Center
Pensacola, Florida, 32503
FirstMed East (J Lewis Research)
Salt Lake City, Utah, 84121
Advanced Clinical Research - Jordan Ridge Family Medicine
Salt Lake City, Utah, 84123
Tekton Research
San Antonio, Texas, 78240
Khruz Biotechnology Research Institute
San Diego, California, 92102
Montgomery Medical Research /Frontier Clinical Research
Smithfield, North Carolina, 15478
DM Clinical Research
Tomball, Texas, 77375
Cotton O'Neil Clinic; Stormont-Vail Hlth Care
Topeka, Kansas, 66606
ClinPoint Trials
Waxahachie, Texas, 75165
Poland4 sites
Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
Bydgoszcz, 85-030
NZOZ Vitamed
Bydgoszcz, 85-079
Prywatny Gabinet Lekarski
Dębica, 39-200
NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska
Siemianowice Śląskie, 41-103
Spain2 sites
Hospital Universitario 12 de Octubre; Servicio de Pediatria
Madrid, 28041
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, LA Coruña, 15706
Costa Rica1 site
ICIMED Instituto de Investigación en Ciencias Médicas
San José, 10108
Israel1 site
Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
Petah Tikva, 4931807
Mexico1 site
Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
Monterrey, N.L, 64710
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Baloxavir Marboxil, Oseltamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir MarboxilDrug
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.
OseltamivirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Baloxavir Marboxil | Experimental | 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. Receives: Drug: Baloxavir Marboxil |
| Oseltamivir | Active comparator | 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 Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 29
Secondary outcomes (27)
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.
Measured: Days 1 (Post-Dose), 2, 4, 6 and 10
Plasma Concentrations of S-033447 - Sparse PK Population
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm.
Measured: Days 1 (Post-Dose), 2, 4, 6 and 10
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.
Measured: Days 1 (Post-Dose), 2, 4, 6 and 10
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.
Measured: Days 1 (Post-Dose), 2, 4, 6 and 10
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])
Measured: Up to Day 15
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.
Measured: Up to Day 15
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.
Measured: Up to Day 15
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?"
Measured: Up to Day 15
Frequency of Influenza-Related Complications
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Measured: Up to Day 29
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.
Measured: Up to Day 29
Percentage of Participants Requiring Antibiotics
Measured: Up to Day 29
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.
Measured: Day 1 - Day 29
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.
Measured: Day 1 - Day 29
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.
Measured: Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
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)
Measured: Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Measured: Baseline, Day 2, 3 (optional), 4, 6, 10
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Measured: Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Area Under the Curve in Virus Titer
Area under the curve (AUC) in virus titer was calculated using the trapezoidal method.
Measured: Day 1 - Day 29
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.
Measured: Day 1 - Day 10
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.
Measured: Up to Day 10
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.
Measured: Up to Day 10
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.
Measured: Up to Day 10
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.
Measured: Up to Day 10
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.
Measured: Up to Day 10
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.
Measured: Up to Day 10
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.
Measured: 24, 72, 96 and 240 hours post-dose
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.
Measured: 24, 72, 96 and 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start20 Nov 2018
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629184
- Sponsor's protocol ID
- CP40563
- Other IDs
- 2018-002169-21, 2018
- Status last verified
- Apr 2020
- First submitted
- 10 Aug 2018
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Retout S, De Buck S, Gaudreault J, Jolivet S, Duval V, Cosson V, Delporte ML. Population Pharmacokinetic and Exposure-Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post-Exposure Prophylaxis in Children. Clin Pharmacol Ther. 2026 Apr;119(4):1047-1056. doi: 10.1002/cpt.70204. Epub 2026 Jan 21.
PubMed 41566882Baker 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.
PubMed 32516282
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03629184
- Acronym / sponsor ID
- CP40563
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baloxavir Marboxil | Experimental | Drug: Baloxavir MarboxilParticipants 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. |
| Oseltamivir | Active comparator | Drug: OseltamivirParticipants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1 |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baloxavir MarboxilBaloxavir 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. | Drug | Baloxavir Marboxil |
| OseltamivirOseltamivir 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. | Drug | Oseltamivir |
Primary outcome
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.
27 secondary outcomes
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
Time frame: Days 1 (Post-Dose), 2, 4, 6 and 10
Plasma Concentrations of S-033447 - Sparse PK Population
Time frame: Days 1 (Post-Dose), 2, 4, 6 and 10
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Time frame: Days 1 (Post-Dose), 2, 4, 6 and 10
Plasma Concentrations of S-033447 - Extensive PK Population
Time frame: Days 1 (Post-Dose), 2, 4, 6 and 10
Time to Alleviation of Influenza Signs and Symptoms
Time frame: Up to Day 15
Duration of Fever
Time frame: Up to Day 15
Duration of Symptoms
Time frame: Up to Day 15
Time to Return to Normal Health and Activity
Time frame: Up to Day 15
Frequency of Influenza-Related Complications
Time frame: Up to Day 29
Percentage of Participants With Influenza-Related Complications
Time frame: Up to Day 29
Percentage of Participants Requiring Antibiotics
Time frame: Up to Day 29
Time to Cessation of Viral Shedding by Virus Titer
Time frame: Day 1 - Day 29
Time to Cessation of Viral Shedding by RT-PCR
Time frame: Day 1 - Day 29
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Time frame: Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Time frame: Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Time frame: Baseline, Day 2, 3 (optional), 4, 6, 10
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
Area Under the Curve in Virus Titer
Time frame: Day 1 - Day 29
Area Under the Curve in the Amount of Virus RNA (RT-PCR)
Time frame: Day 1 - Day 10
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil
Time frame: Up to Day 10
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.
Time frame: Up to Day 10
Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil
Time frame: Up to Day 10
Maximum Plasma Concentration (Cmax) of S-033447
Time frame: Up to Day 10
Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil
Time frame: Up to Day 10
Time to Maximum Plasma Concentration (Tmax) of S-033447
Time frame: Up to Day 10
Plasma Concentrations of Baloxavir Marboxil by Dosage
Time frame: 24, 72, 96 and 240 hours post-dose
Plasma Concentrations of S-033447 by Dosage
Time frame: 24, 72, 96 and 240 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41566882Retout S, De Buck S, Gaudreault J, Jolivet S, Duval V, Cosson V, Delporte ML. Population Pharmacokinetic and Exposure-Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post-Exposure Prophylaxis in Children. Clin Pharmacol Ther. 2026 Apr;119(4):1047-1056. doi: 10.1002/cpt.70204. Epub 2026 Jan 21.
- Derived from this study: PubMed 32516282Baker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baloxavir Marboxil and Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 37 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Poland, Spain, Costa Rica, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629184, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.