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Anti-viral

Baloxavir Marboxil for Flu (Pebblestone Trial)

Phase 3

Recruiting

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 baseline (day 1); days 4, 6 and 10

Awards & highlights

Pebblestone Trial Summary

This trial tests how well a new flu medicine works in children 1-12 years old.

Who is the study for?

This study is for children aged 1 to under 12 with confirmed influenza, who've shown symptoms within the last 48 hours and tested negative for COVID-19. They shouldn't have taken certain antiviral drugs recently or be severely immunocompromised. Girls who have started their periods are excluded.Check my eligibility

What is being tested?

The trial tests how well Baloxavir Marboxil works before and after a single dose in treating young patients with the flu. It aims to monitor changes in susceptibility to this medication post-treatment.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar antiviral medications include nausea, diarrhea, headache, and potential allergic reactions.

Pebblestone Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1); days 4, 6 and 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1); days 4, 6 and 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1); days 4, 6 and 10 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 Resistance-Associated Pre-Treatment Substitutions

Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions

Secondary outcome measures

Change from Baseline in Viral Titers by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)

Number of Participants with Adverse Events and Serious Adverse Events

Percentage of Participants with Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)

+4 more

Side effects data

From 2020 Phase 4 trial • 481 Patients • NCT04141930

Diarrhea

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Study Drug Eligible

Pebblestone Trial Design

1Treatment groups

Experimental Treatment

Group I: Baloxavir MarboxilExperimental Treatment1 Intervention

Participants will receive a 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,623 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,340 Total Patients Enrolled

Frequently Asked Questions

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

Has Baloxavir Marboxil been granted regulatory approval by the FDA?

"The safety of Baloxavir Marboxil was given a rating of 3, signifying there is substantial clinical data available to back up its efficacy and security."

Answered by AI

Who is eligible to take part in this clinical trial?

"In order to be admitted, participants must possess an active case of influenza and fall within the 1-11 year age range. The study is currently accepting around 600 individuals."

Answered by AI

Is the eligibility criteria for this trial inclusive of individuals over 70 years old?

"This highly specific trial requires that enrollees are between 1 and 11 years old."

Answered by AI

Are there slots available for enrollees in this trial?

"The latest information from clinicaltrials.gov confirms that recruitments for this medical trial are ongoing, with the first advertisement having been posted on November 30th 2023 and most recent updates occurring on November 14th 2023."

Answered by AI

How many individuals have been recruited for this investigation?

"Affirmative. The information available on clinicaltrials.gov attests that this trial, which was first posted on November 30th 2023, is actively enrolling patients. 600 individuals must be enrolled at two separate medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza

2023. "A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06094010.

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