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

Phase 3

Recruiting

• Conditions: Influenza
• Interventions: Drug: Baloxavir Marboxil

• Registration Number: NCT06094010
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Study Start: 2023-11-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-05-11
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Resistance-associated Pre-treatment Substitutions	Day 1 (Baseline)
Percentage of Participants With Resistance-associated Treatment-emergent Substitutions	Days 4, 6 and 10

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Age Groups (<5 years versus ≥ 5 years)	Days 4, 6 and 10
Percentage of Participants With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA)	Days 4, 6 and 10
Percentage of Participants With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status	Days 4, 6 and 10
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Day 29	AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Percentage of Participants With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)	Day 1 (Baseline)
Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)	Baseline (Day 1); Days 4, 6 and 10
Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions	Days 4, 6 and 10

Trial Locations

Locations (43)

Central Alabama Research; 🇺🇸 Birmingham, Alabama, United States

Harrisburg Family Medical Center; 🇺🇸 Harrisburg, Arkansas, United States

Avanza Medical Research Center; 🇺🇸 Pensacola, Florida, United States

Tekton Research - Chamblee Georgia; 🇺🇸 Chamblee, Georgia, United States

Tekton Research Lawrenceville; 🇺🇸 Lawrenceville, Georgia, United States

Velocity Clinical Research at Primary Pediatrics Macon; 🇺🇸 Macon, Georgia, United States

Clinical Research Prime; 🇺🇸 Idaho Falls, Idaho, United States

Kentucky Pediatric Research Center; 🇺🇸 Bardstown, Kentucky, United States

Velocity Clinical Research Lafayette; 🇺🇸 Lafayette, Louisiana, United States

Velocity Clinical Research, Slidell; 🇺🇸 Slidell, Louisiana, United States

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