CLINICAL TRIALS PROFILE FOR XOFLUZA
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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. |
| NCT04712539 ↗ | Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients | Not yet recruiting | M.D. Anderson Cancer Center | Phase 2 | 2021-05-01 | This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone. |
| NCT05170009 ↗ | Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza | Not yet recruiting | Genentech, Inc. | Phase 4 | 2022-01-01 | This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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