A Study to Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination with Standard of Care Neuraminidase Inhibitor in Hospitalized Patients with Severe Influenza

Phase 1

• Conditions: INFLUENZA; MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862; MedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862; MedDRA version: 20.1 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 100000004862; MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-001416-30-BE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-07
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 366

Inclusion Criteria

- 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) A patient with a negative RIDT may be enrolled if influenza is suspected based on local surveillance data or if the patient reports contact with a known case of influenza within the prior 7 days
- The time interval between the onset of symptoms and randomization is within 96 hours
- A score of >= 4 based on the NEWS2
- Patients 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
- For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) women must 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 11
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 191
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 165

Exclusion Criteria

- Patients who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
- Patients who have received baloxavir marboxil for the current influenza infection
- Known contraindication to neuraminidase inhibitors
- Known hypersensitivity to baloxavir marboxil or the drug product excipients
- 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 detected within 24 hours prior to or during screening (according to local laboratory reference ranges):
• 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
- 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
- Known hypersensitivity to baloxavir marboxil or the drug product excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified