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

Primary Purpose

Influenza

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Baloxavir Marboxil
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

1 Year - 11 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Baloxavir Marboxil

    Arm Description

    Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).

    Outcomes

    Primary Outcome Measures

    Percentage of Participants with Resistance-Associated Pre-Treatment Substitutions
    Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions

    Secondary Outcome Measures

    Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Age Groups (<5 years versus ≥ 5 years)
    Percentage of Participants with Novel Treatment-Emergent Mutations in Polymerase Acidic Protein (PA)
    Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Baseline Vaccination Status
    Percentage of Participants with Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)
    Change from Baseline in Viral Titers by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
    Susceptibility to Baloxavir Marboxil by Phenotyping Post-Baseline Samples with Novel Genotypic PA Substitutions
    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).

    Full Information

    First Posted
    October 17, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06094010
    Brief Title
    A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza
    Acronym
    Pebblestone
    Official Title
    A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Patients With Influenza
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 5, 2023 (Anticipated)
    Primary Completion Date
    May 11, 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hoffmann-La Roche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Baloxavir Marboxil
    Arm Type
    Experimental
    Arm Description
    Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).
    Intervention Type
    Drug
    Intervention Name(s)
    Baloxavir Marboxil
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Percentage of Participants with Resistance-Associated Pre-Treatment Substitutions
    Time Frame
    Day 1 (Baseline)
    Title
    Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions
    Time Frame
    Days 4, 6 and 10
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Age Groups (<5 years versus ≥ 5 years)
    Time Frame
    Days 4, 6 and 10
    Title
    Percentage of Participants with Novel Treatment-Emergent Mutations in Polymerase Acidic Protein (PA)
    Time Frame
    Days 4, 6 and 10
    Title
    Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Baseline Vaccination Status
    Time Frame
    Days 4, 6 and 10
    Title
    Percentage of Participants with Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)
    Time Frame
    Day 1 (Baseline)
    Title
    Change from Baseline in Viral Titers by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
    Time Frame
    Baseline (Day 1); Days 4, 6 and 10
    Title
    Susceptibility to Baloxavir Marboxil by Phenotyping Post-Baseline Samples with Novel Genotypic PA Substitutions
    Time Frame
    Days 4, 6 and 10
    Title
    Number of Participants with Adverse Events and Serious Adverse Events
    Description
    Adverse events were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
    Time Frame
    Up to Day 29

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    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. 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reference Study ID Number: CV44536 https://forpatients.roche.com/
    Phone
    888-662-6728 (U.S. Only)
    Email
    global-roche-genentech-trials@gene.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

    Learn more about this trial

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

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