臨床研究等提出・公開システム

A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

completed

Sept. 30, 2019

Interventional

multicenter, randomized, double-blind, placebo-controlled

treatment purpose

3

Index Patients (IPs):
-Diagnosed with acute influenza infection by investigator.
-Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas influenza A/B Assay or other point-of-care / local laboratory results.
-Presence of (a) fever (>=38.0 degrees Celsius per tympanic or rectal thermometer; >=37.5 degrees Celsius per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
-The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less. etc,

All HHCs:
-PCR (-) or RIDT (-) based on cobas influenza A/B Assay or other local point-of-care / local laboratory result at Day 0 Visit. etc,

HHC intended for full study must meet the following additional criteria for study entry:
-No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a pre-existing condition.
-Temperature <38.0 degrees Celsius (tympanic).
-Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.

IPs:
-IPs with severe influenza virus infection requiring inpatient treatment.
-IPs judged by the investigator to be at high risk for complications of influenza.
-IPs weighing less than 40 kg.
-Known hypersensitivity to baloxavir marboxil or the drug product excipients. etc,

HHC:
-Pregnant or within 2 weeks post-partum at screening.
-Immunocompromised.
-Less than 2 years old. etc,

Both

Influenza A and/or B virus infection

investigational material(s)
Generic name etc : baloxavir marboxil
INN of investigational material : baloxavir marboxil
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : oral

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
Percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 Post IP Randomization [Time Frame: Baseline to Day 5 (5 days)]

efficacy
safety
-Percentage of HHCs who become PCR+ for Influenza by Day 9 Post IP Randomization [Time Frame: Baseline to Day 9 (9 days)]
-Percentage of HHCs who become PCR+ for Influenza by Day 5 Post IP Randomization and Develop Influenza Symptoms at any Time During the Study [Time Frame: Baseline to Day 5 (5 days)]
-Percentage of Households with At Least One HHC who Meets Primary Endpoint [Time Frame: Baseline to Day 5 (5 days)]
-Percentage of IPs With Adverse Events (AEs) [Time Frame: Baseline to Day 9 (9 Days)]
etc,

Aug. 09, 2019