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

Last updated: February 13, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Influenza

Treatment

Baloxavir Marboxil

Clinical Study ID

NCT06094010
CV44536
  • Ages 1-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with symptoms suggestive of influenza with diagnosis confirmed by apositive 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 atscreening is 48 hours or less

Exclusion

Exclusion Criteria:

  • Participants with severe influenza virus infection requiring inpatient treatment.

  • Severely immunocompromised participants [including participants receivingimmunosuppressant therapy, or those with cancer or human immunodeficiency virus (HIV) infection] as defined by the investigator.

  • Participants with concurrent (non-influenza) infections requiring systemicanti-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 6months or 5 half-lives, whichever is longer, prior to screening.

  • Treatment with an investigational therapy within 30 days or 5 half-lives, whicheveris 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

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Baloxavir Marboxil
Phase: 3
Study Start date:
November 22, 2023
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Medical Centre "Asklepii", OOD

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

  • Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

  • MHAT " St. Ivan Rilski " Kozloduy

    Kozloduy, 3320
    Bulgaria

    Active - Recruiting

  • MHAT City Clinic - Saint George

    Montana, 3403
    Bulgaria

    Active - Recruiting

  • MHAT Stamen Iliev AD

    Montana, 3400
    Bulgaria

    Completed

  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    Ruse, 7002
    Bulgaria

    Site Not Available

  • MHAT Sliven - Military Medial Academy

    Sliven, 8800
    Bulgaria

    Active - Recruiting

  • MHAT Sliven - Military Medial Academy; Department of Infectious Diseases

    Sliven, 8800
    Bulgaria

    Active - Recruiting

  • AGPSMP Pediatric diseases South park OOD

    Sofia, 1421
    Bulgaria

    Active - Recruiting

  • Medical Center Hera Sofia

    Sofia, 1510
    Bulgaria

    Completed

  • Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics

    Sofia, 1510
    Bulgaria

    Site Not Available

  • NZOZ Salmed

    ??czna, 21-010
    Poland

    Active - Recruiting

  • Centrum Medyczne K2J2

    ?ód?, 92-108
    Poland

    Active - Recruiting

  • IN VIVO Sp. z o.o.

    Bydgoszcz, 85-048
    Poland

    Active - Recruiting

  • NZOZ Vitamed

    Bydgoszcz, 85-079
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Cz?stochowa

    Cz?stochowa, 42-200
    Poland

    Active - Recruiting

  • Niepubliczny Zaklad Opieki Zdrowotnej "Amed"

    Grojec, 05-600
    Poland

    Active - Recruiting

  • Vita Longa Sp. z o.o.

    Katowice, 40-748
    Poland

    Active - Recruiting

  • NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska

    Siemianowice ?l?skie, 41-103
    Poland

    Active - Recruiting

  • Jaroslaw Kierkus Prywatna Prakyka Lekarska

    Warszawa, 00-728
    Poland

    Active - Recruiting

  • Centrum Medyczne K2J2

    Wo?omin, 05-200
    Poland

    Active - Recruiting

  • Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

    Wroc?aw, 53-149
    Poland

    Active - Recruiting

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna 15706
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

    Santiago de Compostela, LA Coruña 15706
    Spain

    Active - Recruiting

  • Hospital Universitario La Fe; Hospital La Fe

    València, Valencia 46026
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre; Servicio de Pediatria

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Completed

  • Hospital Universitari i Politècnic La Fe; Servicio de Urgencias Pediátricas

    Valencia, 46026
    Spain

    Active - Recruiting

  • Central Alabama Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Central Alabama Research; Pediatrics

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas 72432
    United States

    Active - Recruiting

  • Avanza Medical Research Center

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Tekton Research - Chamblee Georgia

    Chamblee, Georgia 30341
    United States

    Site Not Available

  • Tekton Research Lawrenceville

    Lawrenceville, Georgia 30043
    United States

    Site Not Available

  • Velocity Clinical Research at Primary Pediatrics Macon

    Macon, Georgia 31210
    United States

    Active - Recruiting

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Kentucky Pediatric Research Center

    Bardstown, Kentucky 40004
    United States

    Active - Recruiting

  • Velocity Clinical Research Lafayette

    Lafayette, Louisiana 70508
    United States

    Active - Recruiting

  • Velocity Clinical Research, Slidell

    Slidell, Louisiana 31210
    United States

    Completed

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Velocity Clinical Research, Hastings

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Machuca Family Medicine

    Las Vegas, Nevada 89104
    United States

    Active - Recruiting

  • Ohio Pediatric Research Association

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • Frontier Clinical Research

    Smithfield, Pennsylvania 15478
    United States

    Active - Recruiting

  • Coastal Pediatric Research

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Tekton Research - Beaumont

    Beaumont, Texas 77706
    United States

    Active - Recruiting

  • Oak Cliff Research Company, LLC

    Dallas, Texas 75218
    United States

    Completed

  • Oak Cliff Research Company, LLC

    Richardson, Texas 75080
    United States

    Active - Recruiting

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Tekton Research

    San Antonio, Texas 78229
    United States

    Completed

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • Frontier Clinical Research, LLC

    Kingwood, West Virginia 26537
    United States

    Site Not Available

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