A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

NCT06094010 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: CV445362023-504672-22-00
• Study Type: interventional
• Target: 1,100
• Locations: 4 countries
• Sites: 51

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

Outcome Measures

Primary Outcomes (2)

• Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions

  Day 1 (At Baseline)

• Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions

  Days 4, 6 and 10

Secondary Outcomes (9)

• Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years [< 1 Year, ≥ 1 Year to < 5 Years], and 5 to < 12 Years)

  Days 4, 6 and 10

• Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA)

  Days 4, 6 and 10

• Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status

  Days 4, 6 and 10

• Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)

  Day 1 (At Baseline)

• Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

  At Baseline (Day 1); Days 4, 6 and 10

Other Outcomes (1)

• Percentage of HHCs Who Become PCR (+) for Influenza Bearing a PA/I38X Substitution (or Other Identified Substitution) Including All Data up to Day 15

  Up to Day 15

Study Arms (1)

Baloxavir Marboxil

EXPERIMENTAL

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.

Drug: Baloxavir Marboxil

Interventions

Baloxavir Marboxil DRUG

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 \[mg/kg\]).

Also known as: XOFLUZA®; RO7191686

Baloxavir Marboxil

Eligibility Criteria

• Age: 3 Weeks - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• \[A\] 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:

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (51)

Central Alabama Research

Birmingham, Alabama, 35209, United States

RECRUITING

Harrisburg Family Medical Center

Harrisburg, Arkansas, 72432, United States

RECRUITING

Kendall South Medical Center Inc.

Miami, Florida, 33185, United States

RECRUITING

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

RECRUITING

Tekton Research - Chamblee Georgia

Chamblee, Georgia, 30341, United States

WITHDRAWN

Tekton Research Lawrenceville

Lawrenceville, Georgia, 30043, United States

WITHDRAWN

Velocity Clinical Research at Primary Pediatrics Macon

Macon, Georgia, 31210, United States

COMPLETED

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

RECRUITING

Mishawaka Osteopathic Clinic

Mishawaka, Indiana, 46544, United States

RECRUITING

Kentucky Pediatric Research Center

Bardstown, Kentucky, 40004, United States

RECRUITING

Velocity Clinical Research Lafayette

Lafayette, Louisiana, 70508, United States

RECRUITING

Velocity Clinical Research, Slidell

Slidell, Louisiana, 31210, United States

COMPLETED

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, 68803, United States

RECRUITING

Machuca Family Medicine

Las Vegas, Nevada, 89104, United States

RECRUITING

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

RECRUITING

Helios Clinical Research, Inc (former Ventavia Research Group)

Middleburg Heights, Ohio, 44130-3643, United States

RECRUITING

Frontier Clinical Research

Smithfield, Pennsylvania, 15478, United States

RECRUITING

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

RECRUITING

Tekton Research - Beaumont

Beaumont, Texas, 77706, United States

RECRUITING

Oak Cliff Research Company, LLC

Dallas, Texas, 75287, United States

COMPLETED

Mercury Clinical Research

Houston, Texas, 77087, United States

COMPLETED

Pioneer Research Solutions

Houston, Texas, 77099, United States

RECRUITING

Oak Cliff Research Company, LLC

Richardson, Texas, 75287, United States

RECRUITING

Sun Research Institute

San Antonio, Texas, 78215, United States

WITHDRAWN

Tekton Research

San Antonio, Texas, 78229, United States

COMPLETED

Siena Research Network

Sugar Land, Texas, 77479, United States

RECRUITING

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

RECRUITING

Frontier Clinical Research, LLC

Kingwood, West Virginia, 26537, United States

ACTIVE NOT RECRUITING

Medical Centre "Asklepii", OOD

Dupnitsa, 2600, Bulgaria

COMPLETED

MHAT " St. Ivan Rilski " Kozloduy

Kozloduy, 3320, Bulgaria

RECRUITING

MHAT Stamen Iliev AD

Montana, 3400, Bulgaria

COMPLETED

MHAT City Clinic - Saint George

Montana, 3403, Bulgaria

RECRUITING

SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

Rousse, 7002, Bulgaria

COMPLETED

MHAT Sliven - Military Medial Academy

Sliven, 8800, Bulgaria

RECRUITING

AGPSMP Pediatric diseases South park OOD

Sofia, 1421, Bulgaria

RECRUITING

Medical Center Hera Sofia

Sofia, 1510, Bulgaria

COMPLETED

IN VIVO Sp. z o.o.

Bydgoszcz, 85-048, Poland

RECRUITING

NZOZ Vitamed

Bydgoszcz, 85-079, Poland

RECRUITING

Centrum Medyczne Pratia Częstochowa

Częstochowa, 42-200, Poland

RECRUITING

Niepubliczny Zaklad Opieki Zdrowotnej "Amed"

Grójec, 05-600, Poland

RECRUITING

Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

RECRUITING

Centrum Medyczne K2J2

Lodz, 92-108, Poland

COMPLETED

NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska

Siemianowice Śląskie, 41-103, Poland

RECRUITING

Jaroslaw Kierkus Prywatna Prakyka Lekarska

Warsaw, 04-501, Poland

RECRUITING

Centrum Medyczne K2J2

Wo?omin, 05-200, Poland

WITHDRAWN

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

Wroclaw, 53-149, Poland

RECRUITING

NZOZ Salmed

Łęczna, 21-010, Poland

RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, 15706, Spain

WITHDRAWN

Hospital Infantil Universitario Nino Jesus

Madrid, 28009, Spain

WITHDRAWN

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

WITHDRAWN

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

COMPLETED

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (28); PL (11); ES (4); BU (8)