A Study of Susceptibility to Baloxavir Marboxil in Patients with Influenza
- Conditions
- InfluenzaMedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862Therapeutic area: Health Care [N] - Environment and Public Health [N06]Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-504672-22-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 610
Patients with symptoms suggestive of influenza with diagnosis confirmed by a positive local influenza test [rapid influenza diagnostic test (RIDT), or Liat® , or polymerase chain react (PCR); for European Union (EU) sites, the test must be in compliance with In Vitro Diagnostic Regulation (IVDR)] within 24 hours before full study screening, Patients with a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (rapid diagnostic test, or Liat® , or PCR; for E.U. sites, the test must be in compliance with IVDR) within 48 hours before full study screening, The time interval of 48 hours or less between the onset of influenza symptoms and the start of pre-dose examinations at screening, Patients or their parents/caregivers who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the pre-dose examinations appropriately
Patients with severe influenza virus infection requiring inpatient treatment, Severely immunocompromised patients [including patients receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus (HIV) infection] as defined by the investigator, Patients 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 and/or 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the prevalence of pre-dose and treatment-emergent<br>polymerase acidic protein (PA) I38X substitutions and other resistanceassociated PA substitutions by type and subtype of influenza virus from<br>patients treated with baloxavir marboxil;Secondary Objective: To evaluate the virologic characteristics of circulating and post-treatment viruses in patients treated with baloxavir marboxil, To further evaluate the safety of a single dose of baloxavir marboxil by assessing the frequency, severity and timing of adverse events;Primary end point(s): Incidence of resistance-associated pre-treatment substitutions determined at baseline (Day 1), Incidence of resistance-associated treatment-emergent substitutions based on sampling on Days 4, 6 and 10
- Secondary Outcome Measures
Name Time Method