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InfluenzaPhase 3PebblestoneNCT06094010

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

A Phase 3 study testing Baloxavir Marboxil in people with Influenza, run by Hoffmann-La Roche at 51 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 3 weeks to 11 years
Conditions the study is for
Influenza
What is being tested?
Baloxavir Marboxil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
51 sitesin 4 countries
Study dates
22 Nov 2023to 30 Jun 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 weeks to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 20Show fewer
  • [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:
  • Fulfills the "partial HHC" criteria
  • Agrees to participate in the full study
  • Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits
  • No influenza symptoms within 7 days prior to screening
  • Does not have a moderate or worse active infections or infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic/antiviral/antifungal therapy

Who cannot join

  • 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
Show all 11Show fewer
  • Known hypersensitivity to baloxavir marboxil or the drug product excipients
  • Females who have commenced menarche (i.e., child-bearing potential)
  • IPs who fulfil an exclusion criterion for Part A
  • 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

Trial locations and contacts

51 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

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

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

51 sites in 4 countries

United States28 sites, 11 recruiting

  • Kentucky Pediatric Research Center

    Bardstown, Kentucky, 40004

    Recruiting

  • Tekton Research - Beaumont

    Beaumont, Texas, 77706

    Completed

  • Central Alabama Research

    Birmingham, Alabama, 35209

    Recruiting

  • Tekton Research - Chamblee Georgia

    Chamblee, Georgia, 30341

    Withdrawn

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

    Completed

  • Oak Cliff Research Company, LLC

    Dallas, Texas, 75287

    Completed

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414

    Completed

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803

    Completed

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

    Recruiting

  • Mercury Clinical Research

    Houston, Texas, 77087

    Completed

  • Pioneer Research Solutions

    Houston, Texas, 77099

    Recruiting

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

    Recruiting

  • Frontier Clinical Research, LLC

    Kingwood, West Virginia, 26537

    Active, not recruiting

  • Velocity Clinical Research Lafayette

    Lafayette, Louisiana, 70508

    Recruiting

  • Machuca Family Medicine

    Las Vegas, Nevada, 89104

    Completed

  • Tekton Research Lawrenceville

    Lawrenceville, Georgia, 30043

    Withdrawn

  • Velocity Clinical Research at Primary Pediatrics Macon

    Macon, Georgia, 31210

    Completed

  • Kendall South Medical Center Inc.

    Miami, Florida, 33185

    Recruiting

  • Helios Clinical Research, Inc (former Ventavia Research Group)

    Middleburg Heights, Ohio, 44130-3643

    Recruiting

  • Mishawaka Osteopathic Clinic

    Mishawaka, Indiana, 46544

    Recruiting

  • Avanza Medical Research Center

    Pensacola, Florida, 32503

    Withdrawn

  • Oak Cliff Research Company, LLC

    Richardson, Texas, 75287

    Completed

  • Sun Research Institute

    San Antonio, Texas, 78215

    Withdrawn

  • Tekton Research

    San Antonio, Texas, 78229

    Completed

  • Velocity Clinical Research, Slidell

    Slidell, Louisiana, 31210

    Completed

  • Frontier Clinical Research

    Smithfield, Pennsylvania, 15478

    Recruiting

  • Siena Research Network

    Sugar Land, Texas, 77479

    Recruiting

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

    Withdrawn

Other trials in United States

Poland11 sites, 8 recruiting

  • IN VIVO Sp. z o.o.

    Bydgoszcz, 85-048

    Recruiting

  • NZOZ Vitamed

    Bydgoszcz, 85-079

    Recruiting

  • Centrum Medyczne Pratia Częstochowa

    Częstochowa, 42-200

    Recruiting

  • Niepubliczny Zaklad Opieki Zdrowotnej "Amed"

    Grójec, 05-600

    Recruiting

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

    Recruiting

  • NZOZ Salmed

    Łęczna, 21-010

    Recruiting

  • Centrum Medyczne K2J2

    Lodz, 92-108

    Completed

  • NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska

    Siemianowice Śląskie, 41-103

    Recruiting

  • Jaroslaw Kierkus Prywatna Prakyka Lekarska

    Warsaw, 04-501

    Withdrawn

  • Centrum Medyczne K2J2

    Wo?omin, 05-200

    Withdrawn

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

    Wroclaw, 53-149

    Recruiting

Other trials in Poland

Bulgaria8 sites, 1 recruiting

  • Medical Centre "Asklepii", OOD

    Dupnitsa, 2600

    Completed

  • MHAT " St. Ivan Rilski " Kozloduy

    Kozloduy, 3320

    Completed

  • MHAT Stamen Iliev AD

    Montana, 3400

    Completed

  • MHAT City Clinic - Saint George

    Montana, 3403

    Completed

  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    Rousse, 7002

    Completed

  • MHAT Sliven - Military Medial Academy

    Sliven, 8800

    Completed

  • AGPSMP Pediatric diseases South park OOD

    Sofia, 1421

    Recruiting

  • Medical Center Hera Sofia

    Sofia, 1510

    Completed

Other trials in Bulgaria

Spain4 sites

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

    Withdrawn

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Withdrawn

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706

    Withdrawn

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

    Completed

Other trials in Spain

About this study

Official title: A Phase IIIb Multicenter, Single-arm, Open-label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts

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
Being tested
Baloxavir Marboxil
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baloxavir MarboxilDrug

    Also called XOFLUZA®; RO7191686

    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]).

Study groups in NCT06094010
Study groupRoleWhat they receive
Baloxavir MarboxilExperimentalParticipants 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.
Receives: Drug: Baloxavir Marboxil

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 (At Baseline)

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

    Measured: Days 4, 6 and 10

Secondary outcomes (9)

  1. 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)

    Measured: Days 4, 6 and 10

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

    Measured: Days 4, 6 and 10

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

    Measured: Days 4, 6 and 10

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

    Measured: Day 1 (At Baseline)

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

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

  6. Part A: Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions

    Measured: Days 4, 6 and 10

  7. Part A: Number of IPs with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

    Measured: Up to Day 29

  8. Part B: Percentage of HHCs With Transmission of Influenza Virus by Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP

    Measured: Day 6, Day 10

  9. Part B: Percentage of HHCs Who Develops Influenza Symptoms With Transmission of Influenza Virus Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP

    Measured: Day 6, Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start22 Nov 2023
  3. Primary completion11 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094010
Sponsor's protocol ID
CV44536
Other IDs
2023-504672-22-00, 2023
Acronym
Pebblestone
Status last verified
Oct 2026
First submitted
17 Oct 2023
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

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