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A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: t
View:

⁃ Index Participants (Participants With Influenza Virus Infection):

• First participant in a household with influenza virus infection in the current influenza season

• Fewer than 6 HHCs

• Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study

• Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result

• Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form

• PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test

⁃ HHCs of Index Participants:

• Lived with the index participant for 48 hours or more prior to informed consent/assent

• Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) \<37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza

• For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary

• PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test

Locations
Other Locations
China
The First People's Hospital of Changde
RECRUITING
Changde
Zhujiang Hospital, Southern Medical University
RECRUITING
Guangzhou
Huizhou Central People's Hospital
RECRUITING
Huizhou
Mianyang Central Hospital
RECRUITING
Mianyang
Ningbo No.2 Hospital
RECRUITING
Ningbo
Sanmenxia Central Hospital
RECRUITING
Sanmenxia
Huashan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Xiamen Maternal and Child Health Hospital
RECRUITING
Xiamen
Contact Information
Primary
Roche Pharma (Schweiz) AG Reference Study ID Number: YV46459, https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Backup
Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-10-16
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 325
Treatments
Experimental: Baloxavir Marboxil
HHCs will receive baloxavir marboxil according to their body weight as outlined in the protocol.
Placebo_comparator: Placebo
HHCs will receive baloxavir marboxil matching placebo according to their body weight as outlined in the protocol.
No_intervention: No Intervention
Index participants will not receive any study treatment but will continue to receive SOC treatment for influenza, as per the local guidelines.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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