Baloxavir Marboxil for Flu
(Pebblestone Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you have not taken certain flu medications like baloxavir marboxil, oseltamivir, or others within 30 days before joining. If you're on these, you might need to stop them before participating.
Is Baloxavir Marboxil safe for human use?
How is the drug Baloxavir Marboxil unique for treating the flu?
What is the purpose of this trial?
This trial is testing a flu medicine called baloxavir marboxil in children aged 1 to under 12 years. The medicine is given as a single dose and aims to stop the flu virus from spreading in the body, making the illness less severe and shorter. Baloxavir marboxil has been shown to reduce the duration of influenza symptoms by approximately one day.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This study is for children aged 1 to under 12 with confirmed influenza, who've shown symptoms within the last 48 hours and tested negative for COVID-19. They shouldn't have taken certain antiviral drugs recently or be severely immunocompromised. Girls who have started their periods are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of baloxavir marboxil on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Baloxavir Marboxil
Baloxavir Marboxil is already approved in United States, Japan, European Union for the following indications:
- Acute uncomplicated influenza within 2 days of illness onset in people aged ≥5 years who are otherwise healthy, or in people aged ≥12 years who are at high risk of developing influenza-related complications
- Influenza A and B virus infections
- Treatment of uncomplicated influenza in adults and adolescents aged 12 years and older weighing at least 40 kg
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University