Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
Official Title
A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts
Quick Facts
Study Start:2023-11-22
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Central Alabama Research
Birmingham, Alabama, 35209
United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432
United States
Avanza Medical Research Center
Pensacola, Florida, 32503
United States
Tekton Research - Chamblee Georgia
Chamblee, Georgia, 30341
United States
Tekton Research Lawrenceville
Lawrenceville, Georgia, 30043
United States
Velocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia, 31210
United States
Clinical Research Prime
Idaho Falls, Idaho, 83404
United States
Kentucky Pediatric Research Center
Bardstown, Kentucky, 40004
United States
Velocity Clinical Research Lafayette
Lafayette, Louisiana, 70508
United States
Velocity Clinical Research, Slidell
Slidell, Louisiana, 31210
United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
United States
Machuca Family Medicine
Las Vegas, Nevada, 89104
United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414
United States
Frontier Clinical Research
Smithfield, Pennsylvania, 15478
United States
Coastal Pediatric Research
Charleston, South Carolina, 29414
United States
Tekton Research - Beaumont
Beaumont, Texas, 77706
United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75218
United States
Oak Cliff Research Company, LLC
Richardson, Texas, 75080
United States
Sun Research Institute
San Antonio, Texas, 78215
United States
Tekton Research
San Antonio, Texas, 78229
United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537
United States
Collaborators and Investigators
Sponsor: Hoffmann-La Roche
- Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2023-11-22
Study Completion Date2027-06-30
Study Record Updates
Study Start Date2023-11-22
Study Completion Date2027-06-30
Terms related to this study
Additional Relevant MeSH Terms