Baloxavir Marboxil for Influenza

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
InfluenzaBaloxavir Marboxil - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This trial will test the safety, how well the drug works, and how it is processed in the body of infants with flu-like symptoms.

Eligible Conditions
  • Influenza

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Day 2, 4, 6, 10, 15, 29

Day 2
Change from Baseline in Influenza Virus Titer and in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 29
Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR)
Time to Cessation of Viral Shedding by Virus Titer and by RT-PCR
Day 4
Plasma Concentrations of Baloxavir Marboxil and S-033447
Day 2
Percentage of Participants with Positive Influenza Virus Titer and Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Up to Day 10
Apparent Half-Life (T1/2) of baloxavir marboxil and S-033447
Area Under the Concentration to Time Curve from Time 0 to Infinity (AUC0-inf) of baloxavir marboxil and S-033447
Maximum Plasma Concentration (Cmax) of baloxavir marboxil and S-033447
Time to Maximum Plasma Concentration (Tmax) of baloxavir marboxil and S-033447
Up to Day 15
Duration of Fever
Duration of Symptoms
Time to Alleviation of Influenza Signs and Symptoms
Time to Return to Normal Health and Activity
Up to Day 29
Frequency of Influenza-Related Complications
Percentage of Participants Requiring Antibiotics
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Study Drug Eligible
1%Diarrhea
1%Headache
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04141930) in the Study Drug Eligible ARM group. Side effects include: Diarrhea with 1%, Headache with 1%.

Trial Design

1 Treatment Group

Baloxavir Marboxil
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Baloxavir Marboxil · No Placebo Group · Phase 3

Baloxavir Marboxil
Drug
Experimental Group · 1 Intervention: Baloxavir Marboxil · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baloxavir marboxil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 2, 4, 6, 10, 15, 29

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,068,053 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Parent/guardian must be willing and able to comply with study requirements, in the investigator's judgment.
The time interval between the onset of symptoms and screening is less than 96 hours.
You have a negative prescreening COVID-19 test (RAT or PCR) within 48 hours of screening.
You have at least one respiratory symptom.