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NCT06094010 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 3
Development phase
750
Enrollment target
20
Study locations

NCT06094010 is a Phase 3 study of Influenza that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 750 participants, below the 36,799-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT06094010, a Phase 3 study of Influenza, is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 3
Development phase
750 participants
Enrollment target
20
Study locations

Study 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' susceptibility \<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.

Conditions Studied

Influenza

Interventions

  • DRUG Baloxavir Marboxil

Study Locations (20)

Georgia

  • Tekton Research - Chamblee Georgia - Chamblee
  • Tekton Research Lawrenceville - Lawrenceville
  • Velocity Clinical Research at Primary Pediatrics Macon - Macon

Florida

  • Kendall South Medical Center Inc. - Miami
  • Avanza Medical Research Center - Pensacola

Louisiana

  • Velocity Clinical Research Lafayette - Lafayette
  • Velocity Clinical Research, Slidell - Slidell

Ohio

  • Ohio Pediatric Research Association - Dayton
  • Helios Clinical Research, Inc (former Ventavia Research Group) - Middleburg Heights

Texas

  • Tekton Research - Beaumont - Beaumont
  • Oak Cliff Research Company, LLC - Dallas

Alabama

  • Central Alabama Research - Birmingham

Arkansas

  • Harrisburg Family Medical Center - Harrisburg

Idaho

  • Clinical Research Prime - Idaho Falls

Trial Details

FieldValue
Enrollment Target 750 participants
Start Date 2023-11-22
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06094010

The ClinicalTrials.gov registry entry for NCT06094010 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,799-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Baloxavir Marboxil is the first listed.

NCT06094010 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Georgia, Florida, Louisiana.

Frequently Asked Questions

What is clinical trial NCT06094010 about?

NCT06094010 is a clinical study titled "A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants 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' susceptibility \<12 years with influenza treated with baloxavir marboxil. P...

What is the current status of trial NCT06094010?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2023-11-22. Estimated completion is 2027-06-30.

What conditions does trial NCT06094010 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT06094010?

The interventions under investigation include: Baloxavir Marboxil (DRUG).

Who is sponsoring clinical trial NCT06094010?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06094010 being conducted?

This trial has 20 study locations across Alabama, Arkansas, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.