Clinical trial NCT06774859: Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
Official title: A Phase III, Randomized, Open-Label, Active-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Patients 1 to <12 Years of Age With Influenza Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to \< 12 years with influenza symptoms.


Eligibility criteria: Inclusion Criteria:

* A participant who has a diagnosis of influenza virus infection and meets all the following conditions:

  * Fever ≥ 38°C (tympanic temperature) at screening
  * At least one of the respiratory symptoms of influenza virus infection
* A rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) shows positive for influenza A/B, e.g., point-of-care/local laboratory results with use of nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)
* The time interval between the onset of symptoms and screening is ≤ 48 hours
* PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care/local laboratory test with nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)

Exclusion Criteria:

* A participant having severe influenza virus infection symptoms requiring inpatient treatment
* Received systemic corticosteroid or immunosuppressive therapy
* Primary immunodeficiency syndrome
* History of organ transplantation
* Human immunodeficiency virus (HIV) infection
* Immunization with a live/attenuated influenza vaccine in 2 weeks prior to randomization
* Previous malignancy within the last 5 years or has an active cancer at any site
* A participant who received any medications with anti-flu effect such as baloxavir, peramivir, oseltamivir, zanamivir, favipiravir, arbidol, amantadine or traditional Chinese anti-influenza medicines within 30 days before screening
* Diagnosed with or suspected SARS-CoV-2 infection, or close contacts of diagnosed or suspected SARS-CoV-2 infected patients
* Severe underlying disease or condition potentially affecting study evaluation in the opinion of the investigator/sub-investigator
* A participant who received an investigational or unapproved drug product within 30 days or 5 x the half-life before screening, whichever is longer

Primary outcomes:
measure: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 29
Secondary outcomes:
measure: Time to Alleviation of Influenza Signs and Symptoms
timeFrame: Up to Day 15
measure: Duration of Fever
timeFrame: Up to Day 15
measure: Duration of Symptoms
timeFrame: Up to Day 15
measure: Time to Return to Normal Health and Activity Based on the CARIFS Questionnaire
timeFrame: Up to Day 15
measure: Frequency of Influenza-Related Complications
timeFrame: Up to Day 29
measure: Percentage of Participants Requiring Antibiotics for Influenza Related Complications
timeFrame: Up to Day 29
measure: Time to Cessation of Viral Shedding as Assessed by Virus Titer
timeFrame: Day 1 to Day 29
measure: Time to Cessation of Viral Shedding as Assessed by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
timeFrame: Day 1 to Day 29
measure: Change From Baseline in Influenza Virus Titer
timeFrame: Baseline (Day 1), Day 2, 4, 6, 10, 15 and 29
measure: Change From Baseline in the Amount of Virus RNA (Based on RT-PCR)
timeFrame: Baseline (Day 1), Day 2, 4, 6, 10, 15 and 29
measure: Percentage of Participants With Positive Influenza Virus Titer
timeFrame: Day 2, 4, 6, 10, 15 and 29
measure: Percentage of Participants With Positive for Influenza Virus as Assessed by RT-PCR
timeFrame: Day 2, 4, 6, 10, 15 and 29
measure: Area Under the Curve (AUC) in Virus Titer
timeFrame: Day 1 to Day 29
measure: Area Under the Curve in Amount of Virus RNA (Based on RT-PCR)
timeFrame: Day 1 to Day 29
measure: Plasma Concentrations of S-033447
timeFrame: Up to 72 hours post dose
measure: Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) of S-033447
timeFrame: Up to Day 10
measure: Maximum Observed Concentration (Cmax) of S-033447
timeFrame: Up to Day 10
measure: Time of Maximum Observed Concentration (Tmax) of S-033447
timeFrame: Up to Day 10
measure: Elimination Half-life (t1/2) of S-033447
timeFrame: Up to Day 10
measure: Polymorphic and Treatment-emergent Amino Acid Substitutions in the PA Gene
timeFrame: Baseline (Day 1) up to Day 29
measure: Effective Concentration (EC50) of Baloxavir Marboxil Evaluated by ViroSpot™ Assay
timeFrame: Up to Day 29
measure: Percentage of Participants with Responses to Palatability and Acceptability Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Changde
country: China
facility: The First People's Hospital of Changde
city: Changsha
country: China
facility: Peoples Hospital of Hunan Province
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
city: Chongqing City
country: China
facility: Chongqing University Jiangjin Hospital
city: Chongqing City
country: China
facility: Childern's Hospital of Chongqing Medical University
city: Langfang City
country: China
facility: Cnpc Central Hospital
city: Liaocheng City
country: China
facility: Liaocheng people's Hospital
city: Linfen City
country: China
facility: Linfen Central Hospital
city: Liuzhou City
country: China
facility: Liuzhou People's Hospital
city: Ningbo City
country: China
facility: Ningbo Women and Children's Hospital
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
city: Sanya
country: China
facility: The Third People's Hospital of Hainan Province
city: Shantou City
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College
city: Shaoyang
country: China
facility: The First Affiliated Hospital, Shaoyang University
city: Shenzhen City
country: China
facility: University of Chinese Academy of Sciences Shenzhen Hospital
city: Xiamen City
country: China
facility: Xiamen Maternal and Child Health Hospital
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: