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 PATIENTS WITH SEVERE INFLUENZA
- Conditions
- -J10J10
- Registration Number
- PER-044-18
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
•Adult patients: Signed informed consent by any patient capable of giving consent, or, where the patient is not capable of giving consent, by his or her legal/authorized representative.
•Adolescent patients not able to legally consent: written informed consent for study participation is obtained from patient’s parents or legal guardian, with assent as appropriate by the patient, depending on the patient’s level of understanding and capability to provide assent.
•Age ≥ 12 years at the time of signing the Informed Consent Form/Assent Form.
•Ability to comply with the study protocol, in the investigator’s judgment.
•Patients 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).
•Patients will require objective criteria of seriousness defined by the protocol.
•For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) 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.
•Patients who have received more than 48 hours of antiviral treatment for influenza prior to screening.
•Patients who have received baloxavir marboxil for the current influenza infection.
•Known contraindication to neuraminidase inhibitors.
•Patients hospitalized for exclusively social reasons (e.g., lack of caregivers at home).
•Patients expected to die or be discharged within 48 hours, according to the investigator’s judgement.
•Patients weighing 40 kg.
•Patients with known severe renal impairment (estimated glomerular filtration rate 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
•Patients with any of the following laboratory abnormalities: ALT or 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; detected within 24 hours prior to or during screening, according to local laboratory reference ranges.
•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 patient’s safe participation in and completion of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Time to hospital discharge and National Early Warning Score 2 (NEWS 2)<br>Measure:Time to Clinical Improvement (TTCI), defined as time to hospital discharge or time to National Early Warning Score 2 (NEWS2)<br>of ≤ 2 maintained for 24 hours.<br><br>Timepoints:Up to Day 35<br>
- Secondary Outcome Measures
Name Time Method