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

Purpose

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.

Condition

Influenza

Eligibility

Eligible Ages: Between 1 Year and 11 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Baloxavir Marboxil	Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).	Drug: Baloxavir Marboxil Baloxavir marboxil will be administered as oral suspension either as 2 milligrams per kilogram (mg/kg) (if weight < 20 kilograms [kg]), or 40 milligrams (mg) (if weight ≥ 20 kg to < 80 kg) or 80 mg (if weight ≥ 80 kg).

Recruiting Locations

Central Alabama Research
Birmingham, Alabama 35209

Harrisburg Family Medical Center
Harrisburg, Arkansas 72432

Avanza Medical Research Center
Pensacola, Florida 32503

Clinical Research Prime
Idaho Falls, Idaho 83404

Kentucky Pediatric Research Center
Bardstown, Kentucky 40004

Velocity Clinical Research Lafayette
Lafayette, Louisiana 70508

Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803

Machuca Family Medicine
Las Vegas, Nevada 89104

Ohio Pediatric Research Association
Dayton, Ohio 45414

Frontier Clinical Research
Smithfield, Pennsylvania 15478

Coastal Pediatric Research
Charleston, South Carolina 29414

Tekton Research - Beaumont
Beaumont, Texas 77706

Oak Cliff Research Company, LLC
Richardson, Texas 75080

Sun Research Institute
San Antonio, Texas 78215

Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088

More Details

NCT ID: NCT06094010
Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: CV44536 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.