Recruiting
Phase 3

Baloxavir Marboxil

Sponsor:

Hoffmann-La Roche

Code:

NCT06094010

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Not accepted

Interventions

Baloxavir Marboxil

Study Details

Brief summary:

This study consists of two parts: Part A Surveillance and Part B Transmission.

The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' <12 years with influenza treated with baloxavir marboxil.

Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.

Conditions

Influenza

Study ID

NCT06094010

Start date

Nov 22, 2023

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Not accepted

Inclusion Criteria (Part A):

  • Participants with symptoms suggestive of influenza based on investigator's judgement 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 start of pre-dose examinations at screening is 48 hours or less

Inclusion Criteria (Part B):

\[A\] IP:

  • Eligible to take part in Part A
  • Lives in a household with a HHC willing to be recruited as full HHC

\[B\] HHCs:

\- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility

\[C\] Partial HHC:

  • Starts screening within 1 calendar day after IP treatment
  • Negative influenza and SARS-CoV-2 test at screening after IP's treatment with baloxavir marboxil
  • HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements AND at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening
  • HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements, and at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening.
  • HHC lives with other HHCs (if applicable) who fulfill all the "partial HHC" criteria

\[D\] Full-study HHC:

  • Fulfills the "partial HHC" criteria
  • Agrees to participate in the full study
  • Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits
  • No influenza symptoms within 7 days prior to screening
  • Does not have a moderate or worse active infections or infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic/antiviral/antifungal therapy

Exclusion Criteria (Part A):

  • 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)

Exclusion Criteria (Part B):

  • IPs who fulfil an exclusion criterion for Part A
  • HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice
  • HHCs diagnosed with influenza by health care professional in the past 4 weeks

Study Design

Enrollment

1100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baloxavir Marboxil

Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age). HHCs related to IPs will be enrolled but will not receive treatment.

Interventions

Baloxavir Marboxil

Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms \[kg\]: 80 milligrams \[mg\]; ≥20 kg to < 80 kg: 40 mg; <20 kg: 2 milligrams per kilogram \[mg/kg\]).

Primary outcome measure

  • Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions [ Time Frame: Day 1 (At Baseline) ]
  • Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions [ Time Frame: Days 4, 6 and 10 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: CV44536 https://forpatients.roche.com/

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Central Alabama Research

Recruiting

Birmingham, Alabama, United States, 35209

Harrisburg Family Medical Center

Recruiting

Harrisburg, Arkansas, United States, 72432

Kendall South Medical Center Inc.

Recruiting

Miami, Florida, United States, 33185

Clinical Research Prime

Recruiting

Idaho Falls, Idaho, United States, 83404

Mishawaka Osteopathic Clinic

Recruiting

Mishawaka, Indiana, United States, 46544

Kentucky Pediatric Research Center

Recruiting

Bardstown, Kentucky, United States, 40004

Velocity Clinical Research Lafayette

Recruiting

Lafayette, Louisiana, United States, 70508

Helios Clinical Research, Inc (former Ventavia Research Group)

Recruiting

Middleburg Heights, Ohio, United States, 44130-3643

Frontier Clinical Research

Recruiting

Smithfield, Pennsylvania, United States, 15478

Tekton Research - Beaumont

Recruiting

Beaumont, Texas, United States, 77706

Pioneer Research Solutions

Recruiting

Houston, Texas, United States, 77099

Siena Research Network

Recruiting

Sugar Land, Texas, United States, 77479

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.