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

Roche

Status and phase: Enrolling; Phase 3

Conditions: Influenza

Treatments: Drug: Baloxavir Marboxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06094010

CV44536

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 1 to 11 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Baloxavir Marboxil

Experimental group

Description:

Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).

Treatment:

Drug: Baloxavir Marboxil