Clinical trial NCT06094010: A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza
Official title: A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Patients With Influenza
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Percentage of Participants with Resistance-Associated Pre-Treatment Substitutions
timeFrame: Day 1 (Baseline)
measure: Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions
timeFrame: Days 4, 6 and 10
Secondary outcomes:
measure: Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Age Groups (<5 years versus ≥ 5 years)
timeFrame: Days 4, 6 and 10
measure: Percentage of Participants with Novel Treatment-Emergent Mutations in Polymerase Acidic Protein (PA)
timeFrame: Days 4, 6 and 10
measure: Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Baseline Vaccination Status
timeFrame: Days 4, 6 and 10
measure: Percentage of Participants with Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)
timeFrame: Day 1 (Baseline)
measure: Change from Baseline in Viral Titers by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
timeFrame: Baseline (Day 1); Days 4, 6 and 10
measure: Susceptibility to Baloxavir Marboxil by Phenotyping Post-Baseline Samples with Novel Genotypic PA Substitutions
timeFrame: Days 4, 6 and 10
measure: Number of Participants with Adverse Events and Serious Adverse Events
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Chamblee
country: United States
facility: Tekton Research - Chamblee Georgia
state: Georgia
city: Lawrenceville
country: United States
facility: Tekton Research Lawrenceville
state: Georgia
city: Macon
country: United States
facility: Velocity Clinical Research at Primary Pediatrics Macon
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Bardstown
country: United States
facility: Kentucky Pediatric Research Center
state: Kentucky
city: Lafayette
country: United States
facility: Velocity Clinical Research Lafayette
state: Louisiana
city: Slidell
country: United States
facility: Velocity Clinical Research, Slidell
state: Louisiana
city: Grand Island
country: United States
facility: Velocity Clinical Research, Grand Island
state: Nebraska
city: Las Vegas
country: United States
facility: Machuca Family Medicine
state: Nevada
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Smithfield
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Beaumont
country: United States
facility: Tekton Research - Beaumont
state: Texas
city: Dallas
country: United States
facility: Oak Cliff Research Company, LLC
state: Texas
city: Richardson
country: United States
facility: Oak Cliff Research Company, LLC
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Kingwood
country: United States
facility: Frontier Clinical Research, LLC
state: West Virginia
city: Dupnitsa
country: Bulgaria
facility: Medical Centre "Asklepii", OOD
city: Kozloduy
country: Bulgaria
facility: MHAT " St. Ivan Rilski " Kozloduy
city: Montana
country: Bulgaria
facility: MHAT Stamen Iliev AD
city: Montana
country: Bulgaria
facility: MHAT City Clinic - Saint George
city: Ruse
country: Bulgaria
facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
city: Sliven
country: Bulgaria
facility: MHAT Sliven - Military Medial Academy
city: Sofia
country: Bulgaria
facility: AGPSMP Pediatric diseases South park OOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera Sofia
city: ??czna
country: Poland
facility: NZOZ Salmed
city: ?ód?
country: Poland
facility: Centrum Medyczne K2J2
city: Bydgoszcz
country: Poland
facility: IN VIVO Sp. z o.o.
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Cz?stochowa
country: Poland
facility: Centrum Medyczne Pratia Cz?stochowa
city: Grojec
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Siemianowice ?l?skie
country: Poland
facility: NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
city: Warszawa
country: Poland
facility: Jaroslaw Kierkus Prywatna Prakyka Lekarska
city: Wo?omin
country: Poland
facility: Centrum Medyczne K2J2
city: Wroc?aw
country: Poland
facility: Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
state: LA Coruna
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: