A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Onradivir Tablets in Participants Aged 12 to 17 Years With Uncomplicated Influenza A.
Recruiting
Phase 3
Interventional Study
Influenza
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Ruijin Hospital · Other
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About This Trial
This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Onradivir Tablets in participants aged 12 to 17 years with influenza A virus infection.
The trial plans to enroll approximately 150 adolescent participants (12-17 years) with uncomplicated influenza A, confirmed by rapid antigen/nucleic acid testing and within 48 hours of symptom onset. Elig…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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All participants must meet all of the following criteria:
Aged 12 to 17 years (inclusive), regardless of gender.
Diagnosed with influenza A based on the following criteria:
* Positive for influenza A virus infection by Rapid Antigen Test (RAT) or nucleic acid testing of n…
Contacts