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

Recruiting Phase 3 Interventional Study
Influenza
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 Weeks – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,100 (estimated)
Sponsor
Hoffmann-La Roche · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria (Part A): * 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 …
Contacts

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

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

global-roche-genentech-trials@gene.com

CONTACT