A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

CompletadoFase 3ClinicalTrials.gov

ID: NCT03684044Tipo: INTERVENTIONALInicio: 8 de ene de 2019Fin estimado: 16 de mar de 2020

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Adult participants: Signed informed consent by any participant capable of giving consent, or, where the participant is not capable of giving consent, by his or her legal/authorized representative
Adolescent participants not able to legally consent: written informed consent for study participation is obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the participant's level of understanding and capability to provide assent
Participants who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization
Diagnosis of influenza A and/or B by a positive Rapid Influenza Diagnostic Test (RIDT) or reverse transcriptase-polymerase chain reaction (RT-PCR)
The time interval between the onset of symptoms and randomization is within 96 hours
A score of ≥4 based on the National Early Warning Score 2 (NEWS2)
Participants will require objective criteria of seriousness defined by at least one of the following criteria:
Requires ventilation or supplemental oxygen to support respiration
Has a complication related to influenza that requires hospitalization (e.g., pneumonia, central nervous system involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, asthma or chronic obstructive pulmonary disease (COPD), severe dehydration, myocarditis, pericarditis, exacerbation of ischemic heart disease)
For women of childbearing potential: Agreement to remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method.

Criterios de exclusión

Participants who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
Participants who have received baloxavir marboxil for the current influenza infection
Known contraindication to neuraminidase inhibitors
Participants hospitalized for exclusively social reasons (e.g., lack of caregivers at home)
Participants expected to die or be discharged within 48 hours, according to the investigator's judgement
Participants weighing \< 40 kg
Participants with known severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
Participants with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges:
Alanine Transaminase (ALT) or Aspartate Transaminase (AST) level \> 5 times the upper limit of normal (ULN) OR
ALT or AST \> 3 times the ULN and total bilirubin level \> 2 times the ULN
Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment
Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
Known hypersensitivity to baloxavir marboxil or the drug product excipients

Intervenciones

drug

Baloxavir Marboxil

Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.

other

Placebo

Participants will receive matching placebo on Days 1, 4 and 7.

Ubicaciones

Instituto Medico Platense

La Plata, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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