A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza

• Status: Recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pre-treatment and single-dose post treatment susceptibility of baloxavir marboxil in participants aged 1 to <12 years with influenza.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Baloxavir

Criteria

Inclusion Criteria:

• Participants with symptoms suggestive of influenza with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening.

• Participants with a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 48 hours before full study screening.

• Time interval between onset of influenza symptoms and the pre-dose examinations at screening is 48 hours or less

Exclusion Criteria:

• Participants with severe influenza virus infection requiring inpatient treatment.

• Severely immunocompromised participants [including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus (HIV) infection] as defined by the investigator.

• Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations.

• Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening.

• Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening.

• Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.

• Known hypersensitivity to baloxavir marboxil or the drug product excipients.

• Females who have commenced menarche (i.e., child-bearing potential).