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Clinical Trials/EUCTR2018-002169-21-ES
EUCTR2018-002169-21-ESActive, not recruitingPhase 1

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE (OSELTAMIVIR)-CONTROLLED STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS 1 TO <12 YEARS OF AGE WITH INFLUENZA-LIKE SYMPTOMS

Roche Farma SA que realiza un el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd0 sites173 target enrollmentStarted: September 17, 2018Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
173
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •- Aged 1 to < 12 years at randomization (Day 1)
  • •- Parent/guardian willing and able to comply with study requirements, in the investigator’s judgment
  • •- Patient able to comply with study requirements, depending on the patient’s level of understanding
  • •- Patient with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
  • •? Fever >=38 degrees C (tympanic temperature) at screening
  • •? At least one respiratory symptom (either cough or nasal congestion)
  • •- The time interval between the onset of symptoms and screening is <= 48 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5 degrees C if known, or the time when the first symptom was noticed by patient, parent or caregiver)
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 120
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •- Severe symptoms of influenza virus infection requiring inpatient treatment
  • •- Concurrent infections requiring systemic antiviral therapy at screening
  • •- Require, in the opinion of the investigator, any of the prohibited medication during the study
  • •- Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
  • •- Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
  • •- Concomitant treatment with steroids or other immuno-suppressant therapy
  • •- Known HIV infection or other immunosuppressive disorder
  • •- Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or patients with known chronic renal failure
  • •- Active cancer at any site
  • •- History of organ transplantation
  • •- Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
  • •- Females who have commenced menarche (i.e., child-bearing potential)
  • •- Participation in a clinical trial within 4 weeks or 5 half-lives of exposure to an investigational drug prior to screening, whichever is longer

Investigators

Sponsor
Roche Farma SA que realiza un el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd

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