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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03684044
Registration number
NCT03684044
Ethics application status
Date submitted
24/09/2018
Date registered
25/09/2018
Titles & IDs
Public title
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
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Scientific title
A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza
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Secondary ID [1]
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2018-001416-30
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Secondary ID [2]
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CP40617
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baloxavir Marboxil
Other interventions - Placebo
Experimental: Baloxavir Marboxil - Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.
Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
Placebo comparator: Placebo - Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.
Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
Treatment: Drugs: Baloxavir Marboxil
Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.
Other interventions: Placebo
Participants will receive matching placebo on Days 1, 4 and 7.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Clinical Improvement
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Assessment method [1]
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Time to Clinical Improvement (TTCI) is defined as Time to Hospital Discharge OR Time to NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours.
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Timepoint [1]
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Up to Day 35
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Secondary outcome [1]
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Response Rates of the 6-Point Ordinal Scale at Day 7
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Assessment method [1]
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The ordinal scale categories are:
Category 1) Discharged (or "ready for discharge") Category 2) Non-ICU hospital ward (or "ready for hospital ward") not requiring supplemental oxygen/non-invasive ventilation Category 3) Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen/non-invasive ventilation Category 4) ICU without mechanical (invasive) ventilation (or "ready for ICU admission") Category 5) Mechanical (invasive) ventilation Category 6) Death
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Timepoint [1]
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Day 7
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Secondary outcome [2]
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Time to Clinical Response
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Assessment method [2]
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Time to Clinical Response is based on temperature ranges, oxygen saturation, respiratory status, heart rate, and hospitalization status.
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Timepoint [2]
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Up to Day 35
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Secondary outcome [3]
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Percentage of Participants on Mechanical Ventilation
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Assessment method [3]
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0
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Timepoint [3]
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Up to Day 35
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Secondary outcome [4]
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Duration of Mechanical Ventilation
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Assessment method [4]
0
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Timepoint [4]
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Up to Day 35
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Secondary outcome [5]
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Percentage of Participants Requiring ICU Stay
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Assessment method [5]
0
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Timepoint [5]
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Up to Day 35
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Secondary outcome [6]
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Duration of ICU Stay
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Assessment method [6]
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Timepoint [6]
0
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Up to Day 35
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Secondary outcome [7]
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Time to Clinical Failure
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Assessment method [7]
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Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission, corresponding to ordinal scale categories 6, 5, and 4, respectively, from baseline
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Timepoint [7]
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0
Up to Day 35
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Secondary outcome [8]
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0
Time to Hospital Discharge
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Assessment method [8]
0
0
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Timepoint [8]
0
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Up to Day 35
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Secondary outcome [9]
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Percentage of Participants With Post-Treatment Influenza-Related Complications
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Assessment method [9]
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Influenza-related complications included pneumonia, myositis or rhabdomyolysis, encephalitis or encephalopathy, myocarditis and/or pericarditis, otitis media, sinusitis, exacerbation of COPD/asthma, sepsis, acute lung injury or acute respiratory distress syndrome.
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Timepoint [9]
0
0
Up to Day 35
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Secondary outcome [10]
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0
Mortality Rate at Day 7
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Up to Day 7
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Secondary outcome [11]
0
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Mortality Rate at Day 28
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Up to Day 28
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Secondary outcome [12]
0
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Time to NEWS2 of = 2 Maintained for 24 Hours
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Assessment method [12]
0
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A score of 0 (Range 0 - 3) indicates normal health conditions.
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Timepoint [12]
0
0
Up to Day 35
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Secondary outcome [13]
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Time to Cessation of Viral Shedding by Virus Titer
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Assessment method [13]
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Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of study treatment and first time when the influenza virus titer is below the limit of detection (0.75 log10 TCID50/mL)
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Timepoint [13]
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Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10
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Secondary outcome [14]
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Change From Baseline in Influenza Virus Titer at Each Timepoint
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Assessment method [14]
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Influenza virus titer 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.
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Timepoint [14]
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Days 2, 3, 4, 5, 7, and 10
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Secondary outcome [15]
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Percentage of Participants With Positive Influenza Virus Titer at Each Timepoint
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Assessment method [15]
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Influenza virus titer 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 (log10 TCID50/mL). A lower value indicates lower viral titer.
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Timepoint [15]
0
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Days 2, 3, 4, 5, 7, and 10
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Secondary outcome [16]
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Area Under the Curve in Virus Titer
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Assessment method [16]
0
0
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Timepoint [16]
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Days 1, 2, 3, 4, 5, 7, and 10
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Secondary outcome [17]
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Time to Cessation of Viral Shedding by RT-PCR
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Assessment method [17]
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Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of study treatment and first time when the virus RNA by RT-PCR is below the limit of detection (2.05 for flu A and 2.83 for flu B log10 virus particles/mL)
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Timepoint [17]
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Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10
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Secondary outcome [18]
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Change From Baseline in the Amount of Virus RNA (RT-PCR) at Each Timepoint
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Assessment method [18]
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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)
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Timepoint [18]
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Days 2, 3, 4, 5, 7, and 10
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Secondary outcome [19]
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Percentage of Participants Positive by RT-PCR at Each Timepoint
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Assessment method [19]
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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)
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Timepoint [19]
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Days 2, 3, 4, 5, 7, and 10
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Secondary outcome [20]
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Area Under the Curve in the Amount of Virus RNA (RT-PCR)
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Assessment method [20]
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Timepoint [20]
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Days 1, 2, 3, 4, 5, 7, and 10
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Secondary outcome [21]
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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [21]
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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.
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Timepoint [21]
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Up to Day 35
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Secondary outcome [22]
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Percentage of Participants With AEs and SAEs Leading to Discontinuation From Treatment
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Assessment method [22]
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Discontinuation from study treatment.
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Timepoint [22]
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Up to Day 35
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Secondary outcome [23]
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Percentage of Participants With Any Post-Treatment ALT and AST Above Baseline and >3 × ULN, >5 × ULN, >10 × ULN
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Assessment method [23]
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ALT = alanine aminotransferase AST = aspartate transaminase
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Timepoint [23]
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Up to Day 35
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Secondary outcome [24]
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Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points
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Assessment method [24]
0
0
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Timepoint [24]
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Day 1, 2, 4, 5, 7 and 8
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Secondary outcome [25]
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Area Under the Concentration to Time Curve From Time 0 to 72 Hours (AUC0-72) of Baloxavir
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Assessment method [25]
0
0
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Timepoint [25]
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0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
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Secondary outcome [26]
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Maximum Plasma Concentration (Cmax) of Baloxavir
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Assessment method [26]
0
0
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Timepoint [26]
0
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0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
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Secondary outcome [27]
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Apparent Half-Life (T1/2) of Baloxavir
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Assessment method [27]
0
0
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Timepoint [27]
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0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
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Secondary outcome [28]
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Concentration at 24 Hours (C24) of Baloxavir
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Assessment method [28]
0
0
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Timepoint [28]
0
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0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
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Eligibility
Key inclusion criteria
* Adult participants: Signed informed consent by any participant capable of giving consent, or, where the participant is not capable of giving consent, by his or her legal/authorized representative
* Adolescent participants not able to legally consent: written informed consent for study participation is obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the participant's level of understanding and capability to provide assent
* Participants who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization
* Diagnosis of influenza A and/or B by a positive Rapid Influenza Diagnostic Test (RIDT) or reverse transcriptase-polymerase chain reaction (RT-PCR)
* The time interval between the onset of symptoms and randomization is within 96 hours
* A score of =4 based on the National Early Warning Score 2 (NEWS2)
* Participants will require objective criteria of seriousness defined by at least one of the following criteria:
* Requires ventilation or supplemental oxygen to support respiration
* Has a complication related to influenza that requires hospitalization (e.g., pneumonia, central nervous system involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, asthma or chronic obstructive pulmonary disease (COPD), severe dehydration, myocarditis, pericarditis, exacerbation of ischemic heart disease)
* For women of childbearing potential: Agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
* Participants who have received baloxavir marboxil for the current influenza infection
* Known contraindication to neuraminidase inhibitors
* Participants hospitalized for exclusively social reasons (e.g., lack of caregivers at home)
* Participants expected to die or be discharged within 48 hours, according to the investigator's judgement
* Participants weighing < 40 kg
* Participants with known severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
* Participants with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges:
* Alanine Transaminase (ALT) or Aspartate Transaminase (AST) level > 5 times the upper limit of normal (ULN) OR
* ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN
* Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment
* Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
* Known hypersensitivity to baloxavir marboxil or the drug product excipients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/03/2020
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Sample size
Target
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Accrual to date
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Final
363
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane & Womens Hospital; Pharmacy Department - Herston
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Recruitment hospital [2]
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Royal Children's Hospital Melbourne - PIN - Parkville
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
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California
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Country [2]
0
0
United States of America
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State/province [2]
0
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Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Louisiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Michigan
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Missouri
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Montana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Nebraska
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Virginia
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Wisconsin
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Country [14]
0
0
Argentina
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State/province [14]
0
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La Plata
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Country [15]
0
0
Belgium
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State/province [15]
0
0
Bruxelles
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Country [16]
0
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Belgium
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State/province [16]
0
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Leuven
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Country [17]
0
0
Brazil
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State/province [17]
0
0
MG
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Country [18]
0
0
Brazil
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State/province [18]
0
0
RS
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Country [19]
0
0
Brazil
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State/province [19]
0
0
SP
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Country [20]
0
0
Bulgaria
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State/province [20]
0
0
Dimitrovgrad
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Country [21]
0
0
Bulgaria
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State/province [21]
0
0
Haskovo
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Country [22]
0
0
Bulgaria
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State/province [22]
0
0
Montana
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Country [23]
0
0
Bulgaria
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State/province [23]
0
0
Plovdiv
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Country [24]
0
0
Bulgaria
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State/province [24]
0
0
Ruse
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Country [25]
0
0
Bulgaria
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State/province [25]
0
0
Samokov
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Country [26]
0
0
Bulgaria
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State/province [26]
0
0
Sliven
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Country [27]
0
0
Bulgaria
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State/province [27]
0
0
Smolyan
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Country [28]
0
0
Bulgaria
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State/province [28]
0
0
Sofia
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Country [29]
0
0
Bulgaria
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State/province [29]
0
0
Veliko Tarnovo
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Country [30]
0
0
Bulgaria
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State/province [30]
0
0
Vratsa
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Country [31]
0
0
Canada
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State/province [31]
0
0
Alberta
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Country [32]
0
0
Canada
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State/province [32]
0
0
Ontario
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Country [33]
0
0
Canada
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State/province [33]
0
0
Quebec
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Country [34]
0
0
China
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0
Beijing City
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Country [35]
0
0
China
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State/province [35]
0
0
Beijing
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Country [36]
0
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China
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State/province [36]
0
0
Chengdu
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Country [37]
0
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China
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State/province [37]
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Guangzhou
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0
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China
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Hangzhou
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0
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China
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Nanchang
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China
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Shanghai
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Country [41]
0
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Czechia
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State/province [41]
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Brno
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Czechia
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Kyjov
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Country [43]
0
0
Estonia
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State/province [43]
0
0
Tallinn
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Country [44]
0
0
Finland
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State/province [44]
0
0
Kuopio
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Country [45]
0
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Finland
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State/province [45]
0
0
Oulu
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Country [46]
0
0
Finland
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State/province [46]
0
0
Turku
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Country [47]
0
0
France
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State/province [47]
0
0
Argenteuil
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0
0
France
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State/province [48]
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Dijon
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Country [49]
0
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France
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State/province [49]
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La Roche Sur Yon
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Country [50]
0
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France
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State/province [50]
0
0
Limoges
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Country [51]
0
0
France
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State/province [51]
0
0
Nantes
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0
0
France
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0
0
Nimes
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Country [53]
0
0
France
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Orleans
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Country [54]
0
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France
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0
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Paris
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Country [55]
0
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France
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State/province [55]
0
0
Strasbourg
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Country [56]
0
0
France
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State/province [56]
0
0
Tours
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Country [57]
0
0
Germany
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State/province [57]
0
0
Donaustauf
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Country [58]
0
0
Germany
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State/province [58]
0
0
Dresden
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Country [59]
0
0
Germany
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State/province [59]
0
0
Freiburg im Breisgau
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Country [60]
0
0
Germany
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State/province [60]
0
0
Hannover
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Country [61]
0
0
Germany
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State/province [61]
0
0
Köln
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Country [62]
0
0
Germany
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State/province [62]
0
0
Lubeck
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Country [63]
0
0
Germany
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State/province [63]
0
0
Mannheim
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Country [64]
0
0
Germany
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State/province [64]
0
0
Regensburg
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Country [65]
0
0
Germany
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Tübingen
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0
Hong Kong
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Hong Kong
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Hong Kong
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Shatin, New Territories
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Israel
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Beer Sheva
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Israel
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Holon
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Israel
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Nahariya
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Israel
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Ramat Gan
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Israel
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Rambam
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Israel
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Safed
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Israel
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Tel Aviv
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Israel
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Tiberias
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Japan
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Dategun Kunimimachi
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Japan
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Fukuoka
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Japan
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Izumisano
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Japan
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Joyo
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Japan
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Kanazawa
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Japan
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Kumamoto-shi
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Japan
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Naha
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Japan
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Naka-gun
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Japan
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Nihonmatsu
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Japan
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Osaka
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Japan
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Shibukawa
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Japan
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Shinagawa
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Japan
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Shiogama
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Japan
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Shizuoka
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Japan
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Sukagawa
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Japan
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Tokyo
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Japan
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Yanagawa-shi
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Mexico CITY (federal District)
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Tijuana
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Sittard-Geleen
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Netherlands
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Utrecht
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New Zealand
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Wellington
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Peru
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Callao
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Peru
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Cusco
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Galati
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Romania
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Iasi
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Romania
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Sibiu
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Romania
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Suceava
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Nova Sad
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Serbia
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Sombor
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Serbia
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Sremska Kamenica
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Madrid
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Spain
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Alicante
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Malmö
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Konya
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Turkey
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Trabzon
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Ukraine
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Chernihiv Governorate
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Ukraine
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Katerynoslav Governorate
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Ukraine
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KIEV Governorate
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Ukraine
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Podolia Governorate
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Ukraine
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Odesa
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.
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Trial website
https://clinicaltrials.gov/study/NCT03684044
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Trial related presentations / publications
Stannard HL, Mifsud EJ, Wildum S, Brown SK, Koszalka P, Shishido T, Kojima S, Omoto S, Baba K, Kuhlbusch K, Hurt AC, Barr IG. Assessing the fitness of a dual-antiviral drug resistant human influenza virus in the ferret model. Commun Biol. 2022 Sep 28;5(1):1026. doi: 10.1038/s42003-022-04005-4. Kumar D, Ison MG, Mira JP, Welte T, Hwan Ha J, Hui DS, Zhong N, Saito T, Katugampola L, Collinson N, Williams S, Wildum S, Ackrill A, Clinch B, Lee N. Combining baloxavir marboxil with standard-of-care neuraminidase inhibitor in patients hospitalised with severe influenza (FLAGSTONE): a randomised, parallel-group, double-blind, placebo-controlled, superiority trial. Lancet Infect Dis. 2022 May;22(5):718-730. doi: 10.1016/S1473-3099(21)00469-2. Epub 2022 Jan 24. Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/44/NCT03684044/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/44/NCT03684044/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03684044