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

Influenza Clinical Trial

— Pebblestone  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094010
• Other study ID #: CV44536
• Status: Recruiting
• Phase: Phase 3
• Start date: November 22, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: CV44536 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2027
• Est. primary completion date: May 11, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 11 Years

Eligibility

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.
• The time interval between the 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).

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Baloxavir Marboxil
Baloxavir marboxil will be administered as oral suspension either as 2 milligrams per kilograms (mg/kg) (if weight less than 20 kg), or 40 mg (if weight more than or equal to 20 kg to less than 80 kg) or 80 mg (if weight more than or equal to 80 kg).

Locations

Country	Name	City	State
Bulgaria	Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics	Dupnitsa
Bulgaria	MHAT " St. Ivan Rilski " Kozloduy	Kozloduy
Bulgaria	MHAT City Clinic - Saint George	Montana
Bulgaria	MHAT Stamen Iliev AD	Montana
Bulgaria	SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.	Ruse
Bulgaria	MHAT Sliven - Military Medial Academy; Department of Infectious Diseases	Sliven
Bulgaria	Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics	Sofia
Poland	NZOZ Salmed	??czna
Poland	IN VIVO Sp. z o.o.	Bydgoszcz
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Centrum Medyczne Pratia Cz?stochowa	Cz?stochowa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Amed"	Grojec
Poland	Vita Longa Sp. z o.o.	Katowice
Poland	NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska	Siemianowice ?l?skie
Poland	Jaroslaw Kierkus Prywatna Prakyka Lekarska	Warszawa
Poland	Centrum Medyczne K2J2	Wo?omin
Poland	Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?	Wroc?aw
Spain	Hospital Infantil Universitario Nino Jesus	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Pediatria	Madrid
Spain	Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría	Santiago de Compostela	LA Coruña
Spain	Hospital Universitari i Politècnic La Fe; Servicio de Urgencias Pediátricas	Valencia
United States	Kentucky Pediatric Research Center	Bardstown	Kentucky
United States	Tekton Research - Beaumont	Beaumont	Texas
United States	Central Alabama Research; Pediatrics	Birmingham	Alabama
United States	Tekton Research - Chamblee Georgia	Chamblee	Georgia
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Oak Cliff Research Company, LLC	Dallas	Texas
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Harrisburg Family Medical Center	Harrisburg	Arkansas
United States	Velocity Clinical Research, Hastings	Hastings	Nebraska
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Frontier Clinical Research, LLC	Kingwood	West Virginia
United States	Velocity Clinical Research Lafayette	Lafayette	Louisiana
United States	Machuca Family Medicine	Las Vegas	Nevada
United States	Tekton Research Lawrenceville	Lawrenceville	Georgia
United States	Velocity Clinical Research at Primary Pediatrics Macon	Macon	Georgia
United States	Avanza Medical Research Center	Pensacola	Florida
United States	Oak Cliff Research Company, LLC	Richardson	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Tekton Research	San Antonio	Texas
United States	Velocity Clinical Research, Slidell	Slidell	Louisiana
United States	Frontier Clinical Research	Smithfield	Pennsylvania
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Resistance-Associated Pre-Treatment Substitutions		Day 1 (Baseline)
Primary	Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions		Days 4, 6 and 10
Secondary	Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Age Groups (<5 years versus = 5 years)		Days 4, 6 and 10
Secondary	Percentage of Participants with Novel Treatment-Emergent Mutations in Polymerase Acidic Protein (PA)		Days 4, 6 and 10
Secondary	Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Baseline Vaccination Status		Days 4, 6 and 10
Secondary	Percentage of Participants with Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)		Day 1 (Baseline)
Secondary	Change from Baseline in Viral Titers by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)		Baseline (Day 1); Days 4, 6 and 10
Secondary	Susceptibility to Baloxavir Marboxil by Phenotyping Post-Baseline Samples with Novel Genotypic PA Substitutions		Days 4, 6 and 10
Secondary	Number of Participants with Adverse Events and Serious Adverse Events	Adverse events were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).	Up to Day 29