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A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza - Trial NCT06094010

Access comprehensive clinical trial information for NCT06094010 through Pure Global AI's free database. This Phase 3 trial is sponsored by Hoffmann-La Roche and is currently Recruiting. The study focuses on Influenza. Target enrollment is 600 participants.

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NCT06094010
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06094010
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A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza
A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Patients With Influenza

Study Focus

Influenza

Baloxavir Marboxil

Interventional

drug

Sponsor & Location

Hoffmann-La Roche

Lafayette,Las Vegas, United States of America

Timeline & Enrollment

Phase 3

Nov 30, 2023

Jun 30, 2027

600 participants

Primary Outcome

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

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.

ICD-10 Classifications

Influenza and pneumonia
Influenza due to identified seasonal influenza virus
Influenza with other manifestations, seasonal influenza virus identified
Influenza with pneumonia, seasonal influenza virus identified
Influenza due to identified zoonotic or pandemic influenza virus

Data Source

ClinicalTrials.gov

NCT06094010

Non-Device Trial