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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03684044




Registration number
NCT03684044
Ethics application status
Date submitted
24/09/2018
Date registered
25/09/2018
Date last updated
4/06/2020

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
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
Secondary ID [1] 0 0
2018-001416-30
Secondary ID [2] 0 0
CP40617
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 or its matching placebo on Day 1 and 4. A third dose of Baloxavir or its matching 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. SOC NAI will be administered to cover a minimum of treatment exposure from Day 1 to Day 5

Placebo Comparator: Placebo - Participants will be assigned in a 2:1 ratio to receive baloxavir marboxil or matching placebo.
Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice. SOC NAI will be administered to cover a minimum of treatment exposure from Day 1 to Day 5


Treatment: Drugs: Baloxavir Marboxil
Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose of Baloxavir or its matching placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5
Treatment with a SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) will also be administered in accordance with local clinical practice.

Other interventions: Placebo
Participants will receive Baloxavir marboxil or matching placebo in 2:1 ratio. Treatment with a SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) will also be administered in accordance with local clinical practice.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Clinical Improvement - Time to Clinical Improvement is defined as:
Time to Hospital Discharge OR
Time to NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours
Timepoint [1] 0 0
Up to Day 35
Secondary outcome [1] 0 0
Response Rates of the 6-Point Ordinal Scale at Day 7
Timepoint [1] 0 0
Day 7
Secondary outcome [2] 0 0
Time to Clinical Response - Time to Clinical Response is based on temperature ranges, oxygen saturation, respiratory status, heart rate, and hospitalization status.
Timepoint [2] 0 0
Up to Day 35
Secondary outcome [3] 0 0
Percentage of Participants on Mechanical Ventilation
Timepoint [3] 0 0
Up to Day 35
Secondary outcome [4] 0 0
Duration of Mechanical Ventilation
Timepoint [4] 0 0
Up to Day 35
Secondary outcome [5] 0 0
Percentage of Participants Requiring ICU Stay
Timepoint [5] 0 0
Up to Day 35
Secondary outcome [6] 0 0
Duration of ICU Stay
Timepoint [6] 0 0
Up to Day 35
Secondary outcome [7] 0 0
Time to Clinical Failure - 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
Timepoint [7] 0 0
Up to Day 35
Secondary outcome [8] 0 0
Time to Hospital Discharge
Timepoint [8] 0 0
Up to Day 35
Secondary outcome [9] 0 0
Percentage of Participants with Post-Treatment Influenza-Related Complications
Timepoint [9] 0 0
Up to Day 35
Secondary outcome [10] 0 0
Mortality Rate at Day 7
Timepoint [10] 0 0
Up to Day 7
Secondary outcome [11] 0 0
Mortality Rate at Day 28
Timepoint [11] 0 0
Up to Day 28
Secondary outcome [12] 0 0
Time to NEWS2 of = 2 maintained for 24 hours
Timepoint [12] 0 0
Up to Day 35
Secondary outcome [13] 0 0
Time to Cessation of Viral Shedding by Virus Titer
Timepoint [13] 0 0
Up to Day 35
Secondary outcome [14] 0 0
Time to Cessation of Viral Shedding by RT-PCR
Timepoint [14] 0 0
Up to Day 35
Secondary outcome [15] 0 0
Change from Baseline in Influenza Virus Titer and in the Amount of Virus RNA (RT-PCR) at Each Timepoint
Timepoint [15] 0 0
Up to Day 35
Secondary outcome [16] 0 0
Percentage of Participants with Positive Influenza Virus Titer and Positive by RT-PCR at Each Timepoint
Timepoint [16] 0 0
Up to Day 35
Secondary outcome [17] 0 0
Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR)
Timepoint [17] 0 0
Up to Day 35
Secondary outcome [18] 0 0
Polymorphic and Treatment-Emergent Amino Acid Substitutions in the PA, PB1, PB2, and NA Genes
Timepoint [18] 0 0
Up to Day 35
Secondary outcome [19] 0 0
Drug Susceptibility in Participants with Evaluable Virus
Timepoint [19] 0 0
Up to Day 35
Secondary outcome [20] 0 0
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [20] 0 0
Up to Day 35
Secondary outcome [21] 0 0
Percentage of Participants with AEs Leading to Discontinuation
Timepoint [21] 0 0
Up to Day 35
Secondary outcome [22] 0 0
Percentage of Participants with Any Post-Treatment ALT and AST Above Baseline and >3 × ULN, >5 × ULN, >10 × ULN - ALT = alanine aminotransferase AST = aspartate transaminase
Timepoint [22] 0 0
Up to Day 35
Secondary outcome [23] 0 0
Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points
Timepoint [23] 0 0
Day 1, 2, 4, 5, 7, 8 and Day 11 to Day 30
Secondary outcome [24] 0 0
Area Under the Curve (AUC) of Baloxavir - Only for participants undergoing sequential PK sampling
Timepoint [24] 0 0
Day 1, 2, 4, 5, 7, 8 and Day 11 to Day 30
Secondary outcome [25] 0 0
Maximum Plasma Concentration (Cmax) of Baloxavir - Only for participants undergoing sequential PK sampling
Timepoint [25] 0 0
Day 1, 2, 4, 5, 7, 8 and Day 11 to Day 30
Secondary outcome [26] 0 0
Apparent Half-Life (T1/2) of Baloxavir - Only for patients undergoing sequential PK sampling
Timepoint [26] 0 0
Day 1, 2, 4, 5, 7, 8 and Day 11 to Day 30

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 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, CNS 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.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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:

- ALT or 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital; Outpatient Pharmacy University Clinic - Westmead
Recruitment hospital [2] 0 0
Cairns Base Hospital; Special Health Services - Cairns
Recruitment hospital [3] 0 0
Royal Brisbane & Womens Hospital; Pharmacy Department - Herston
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Monash Health Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Geelong Hospital - Geelong
Recruitment hospital [8] 0 0
Royal Melbourne Hospital; Department of Neurology - Parkville
Recruitment hospital [9] 0 0
Royal Children's Hospital Melbourne - PIN - Parkville
Recruitment hospital [10] 0 0
The Alfred Hospital - Prahan
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3052 - Parkville
Recruitment postcode(s) [10] 0 0
3181 - Prahan
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
Country [3] 0 0
United States of America
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Delaware
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United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
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Louisiana
Country [7] 0 0
United States of America
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Maryland
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United States of America
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Michigan
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Missouri
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Nebraska
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Vermont
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Tourcoing
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Bonn
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Donaustauf
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Dresden
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Essen
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Freiburg im Breisgau
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Hong Kong
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Kowloon
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Hong Kong
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Shatin, New Territories
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Hungary
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Budapest
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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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Rechovot
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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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Dategun Kunimimachi
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Fukuoka
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Joyo
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Kanazawa
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Kumamoto-shi
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Japan
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Naha
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Naka-gun
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Nihonmatsu
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Osaka
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Shibukawa
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Shinagawa
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Shiogama
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Shizuoka
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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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Daegu
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Korea, Republic of
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Daejeon
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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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Seoul
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Guadalajara
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Tijuana
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Netherlands
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'S Hertogenbosch
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Amsterdam
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Apeldoorn
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Netherlands
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EDE
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Netherlands
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Enschede
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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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Utrecht
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Netherlands
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Zwolle
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New Zealand
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Tauranga
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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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Peru
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Lima
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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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Barcelona
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Madrid
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Alicante
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Murcia
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Sevilla
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Valencia
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Goteborg
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Malmö
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Ankara
Country [166] 0 0
Turkey
State/province [166] 0 0
Antalya
Country [167] 0 0
Turkey
State/province [167] 0 0
Istanbul
Country [168] 0 0
Turkey
State/province [168] 0 0
Konya
Country [169] 0 0
Turkey
State/province [169] 0 0
Trabzon
Country [170] 0 0
Ukraine
State/province [170] 0 0
Chernihiv Governorate
Country [171] 0 0
Ukraine
State/province [171] 0 0
Katerynoslav Governorate
Country [172] 0 0
Ukraine
State/province [172] 0 0
KIEV Governorate
Country [173] 0 0
Ukraine
State/province [173] 0 0
Podolia Governorate
Country [174] 0 0
Ukraine
State/province [174] 0 0
Ivano-Frankivsk
Country [175] 0 0
Ukraine
State/province [175] 0 0
Kyiv
Country [176] 0 0
Ukraine
State/province [176] 0 0
Odesa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03684044
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications