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The trial is taking place at:
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Sun Research Institute | San Antonio, TX

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

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Roche

Status and phase

Enrolling
Phase 3

Conditions

Influenza

Treatments

Drug: Baloxavir Marboxil

Study type

Interventional

Funder types

Industry

Identifiers

NCT06094010
CV44536

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

1 to 11 years old

Volunteers

No 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.
  • 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

Baloxavir Marboxil
Experimental group
Description:
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).
Treatment:
Drug: Baloxavir Marboxil

Trial contacts and locations

43

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Central trial contact

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

Data sourced from clinicaltrials.gov

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