A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Recruiting
Phase 3Interventional 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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Review the details below, then apply to join this clinical trial.
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
Who this trial is looking for
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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 …
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.
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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 …
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 (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
Inclusion Criteria (Part B):
\[A\] IP:
* Eligible to take part in Part A
* Lives in a household with a HHC willing to be recruited as full HHC
\[B\] 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
Exclusion Criteria (Part A):
* 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)
Exclusion Criteria (Part B):
* 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
Contacts
Reference Study ID Number: CV44536 https://forpatients.roche.com/
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