RECRUITING

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

Description

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.

Conditions

Influenza
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Related Conditions:

Influenza

Study Overview

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Study Details

Study overview

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.

A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Patients With Influenza

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

Condition
Influenza
Intervention / Treatment

-

Contacts and Locations

Birmingham

Central Alabama Research; Pediatrics, Birmingham, Alabama, United States, 35209

Harrisburg

Harrisburg Family Medical Center, Harrisburg, Arkansas, United States, 72432

Pensacola

Avanza Medical Research Center, Pensacola, Florida, United States, 32503

Chamblee

Tekton Research - Chamblee Georgia, Chamblee, Georgia, United States, 30341

Lawrenceville

Tekton Research Lawrenceville, Lawrenceville, Georgia, United States, 30043

Macon

Velocity Clinical Research at Primary Pediatrics Macon, Macon, Georgia, United States, 31210

Idaho Falls

Clinical Research Prime, Idaho Falls, Idaho, United States, 83404

Bardstown

Kentucky Pediatric Research Center, Bardstown, Kentucky, United States, 40004

Lafayette

Velocity Clinical Research Lafayette, Lafayette, Louisiana, United States, 70508

Slidell

Velocity Clinical Research, Slidell, Slidell, Louisiana, United States, 31210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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).

Ages Eligible for Study

1 Year to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2027-06-30