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Last Updated: November 24, 2020

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CLINICAL TRIALS PROFILE FOR BALOXAVIR MARBOXIL

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All Clinical Trials for Baloxavir Marboxil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03629184 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms Not yet recruiting Hoffmann-La Roche Phase 3 2018-11-16 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.
NCT03653364 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms Not yet recruiting Hoffmann-La Roche Phase 3 2018-12-13 This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms
NCT03684044 Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza Not yet recruiting Hoffmann-La Roche Phase 3 2018-11-30 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.
NCT03959332 Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants Not yet recruiting Shionogi N/A 2019-06-04 This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
NCT03959332 Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants Not yet recruiting Hoffmann-La Roche N/A 2019-06-04 This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
NCT03969212 Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households Not yet recruiting Hoffmann-La Roche Phase 3 2019-05-30 Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screen. Their households are enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs obtained from both IP and HHC up to 9 (+/-1) days post IP randomization.
NCT04141930 Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle Not yet recruiting University of Washington Phase 4 2019-11-01 This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Baloxavir Marboxil

Condition Name

Condition Name for Baloxavir Marboxil
Intervention Trials
Influenza 5
Healthy Volunteer 1
Respiratory Viral Infection 1
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Condition MeSH

Condition MeSH for Baloxavir Marboxil
Intervention Trials
Influenza, Human 5
Virus Diseases 1
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Clinical Trial Locations for Baloxavir Marboxil

Trials by Country

Trials by Country for Baloxavir Marboxil
Location Trials
United States 55
Brazil 6
Ukraine 6
Spain 5
Mexico 5
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Trials by US State

Trials by US State for Baloxavir Marboxil
Location Trials
Texas 4
Colorado 3
New York 3
Nebraska 3
Arizona 2
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Clinical Trial Progress for Baloxavir Marboxil

Clinical Trial Phase

Clinical Trial Phase for Baloxavir Marboxil
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
N/A 1
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Clinical Trial Status

Clinical Trial Status for Baloxavir Marboxil
Clinical Trial Phase Trials
Not yet recruiting 6
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Clinical Trial Sponsors for Baloxavir Marboxil

Sponsor Name

Sponsor Name for Baloxavir Marboxil
Sponsor Trials
Hoffmann-La Roche 5
University of Washington 1
Shionogi 1
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Sponsor Type

Sponsor Type for Baloxavir Marboxil
Sponsor Trials
Industry 6
Other 1
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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
AstraZeneca
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Dow
Express Scripts

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