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CLINICAL TRIALS PROFILE FOR XOFLUZA

All Clinical Trials for XOFLUZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03959332 ↗	Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants	Completed	Shionogi	N/A	2019-06-19	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	Completed	Hoffmann-La Roche	N/A	2019-06-19	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	Recruiting	Hoffmann-La Roche	Phase 3	2019-10-10	Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. 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, and through the assessment of symptoms.
NCT04141930 ↗	Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle	Completed	Genentech, Inc.	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.
NCT04141930 ↗	Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle	Completed	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.

Clinical Trial Conditions for XOFLUZA

Condition Name

Condition Name for XOFLUZA
Intervention	Trials
Influenza	5
Healthy Volunteer	1
Hematopoietic and Lymphoid Cell Neoplasm	1
Influenza, Human	1

Condition MeSH

Condition MeSH for XOFLUZA
Intervention	Trials
Influenza, Human	5
Virus Diseases	1

Clinical Trial Locations for XOFLUZA

Trials by Country

Trials by Country for XOFLUZA
Location	Trials
United States	27
India	9
Brazil	4
Mexico	3
China	2

Trials by US State

Trials by US State for XOFLUZA
Location	Trials
Texas	2
Colorado	1
Pennsylvania	1
South Carolina	1
South Dakota	1

Clinical Trial Progress for XOFLUZA

Clinical Trial Phase

Clinical Trial Phase for XOFLUZA
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for XOFLUZA
Clinical Trial Phase	Trials
Not yet recruiting	3
Completed	2
Recruiting	1

Clinical Trial Sponsors for XOFLUZA

Sponsor Name

Sponsor Name for XOFLUZA
Sponsor	Trials
Hoffmann-La Roche	2
Genentech, Inc.	2
Weill Medical College of Cornell University	1

Sponsor Type

Sponsor Type for XOFLUZA
Sponsor	Trials
Industry	5
Other	4