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NCT03969212 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,138
- Enrollment target
NCT03969212 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 4,138 participants.
The verdict
NCT03969212, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,138 participants
- Enrollment target
Study Summary
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
Interventions
- DRUG Placebo
- DRUG Baloxavir Marboxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,138 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2024-05-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03969212
The ClinicalTrials.gov registry entry for NCT03969212 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03969212 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03969212 about?
NCT03969212 is a clinical study titled "Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households". Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine w...
What is the current status of trial NCT03969212?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,138 participants. The study started on 2019-10-10. Estimated completion is 2024-05-10.
What interventions are being tested in trial NCT03969212?
The interventions under investigation include: Placebo (DRUG), Baloxavir Marboxil (DRUG).
Who is sponsoring clinical trial NCT03969212?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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