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Cap-dependent Endonuclease Inhibitor

Baloxavir Marboxil for Influenza

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2, 4, 6, 10, 15, 29
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2, 4, 6, 10, 15, 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2, 4, 6, 10, 15, 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
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
Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR)
+12 more

Side effects data

From 2020 Phase 4 trial • 481 Patients • NCT04141930
1%
Diarrhea
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Drug Eligible

Trial Design

1Treatment groups
Experimental Treatment
Group I: Baloxavir MarboxilExperimental Treatment1 Intervention
Participants will receive single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baloxavir Marboxil
2019
Completed Phase 4
~4720

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,373 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the possible side effects of taking Baloxavir Marboxil?

"Baloxavir Marboxil received a safety score of 3 because there is efficacy data from Phase 3 trials as well as multiple rounds of safety data."

Answered by AI

At how many different locations can patients enroll in this trial?

"There are 6 locations currently running this trial. They are: The Children's Clinic of Jonesboro, P.A. in Jonesboro, Usf Health in Tampa, OnSite Clinical Solutions LLC in Charlotte, and 6 other locations."

Answered by AI

Can patients sign up for this experimental treatment procedure at this time?

"The trial is currently ongoing, as indicated by information on clinicaltrials.gov. This includes the posting date (2019-01-23) and most recent edit (2022-10-16)."

Answered by AI

How many people fit the qualifications for this research project?

"To move forward, this study requires 30 individuals that fit the specific inclusion criteria. If you are eligible, you can participate in this trial from various locations such as The Children's Clinic of Jonesboro, P.A. in Jonesboro, Arkansas or Usf Health in Tampa, Florida."

Answered by AI

Has this kind of research been conducted before?

"There have been 4 clinical trials for Baloxavir Marboxil over the past two years in 26 countries and 91 cities. The earliest one was in 2019 and it completed its Phase 3 drug approval stage that year. It was sponsored by Hoffmann-La Roche and had 30 participants. Since then, there have been 6 more trials."

Answered by AI

Is Baloxavir Marboxil a new medication?

"At the moment, there are 4 separate clinical trials underway that are studying Baloxavir Marboxil. Of those 4, 3 are in Phase 3. The 350 locations conducting these trials are mostly based in Curitiba, PR."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
2019. "Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03653364.
~8 spots leftby Apr 2025
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