A Phase 3 interventional study of Peramivir and Placebo Comparator in Influenza, sponsored by BioCryst Pharmaceuticals. Withdrawn at 96 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by BioCryst Pharmaceuticals · Phase 3, Interventional, and Treatment
This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute,uncomplicated influenza.
Exclusion Criteria:
Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to \< 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
Drug: Peramivir
Placebo Peramivir, administered intravenously.
Drug: Placebo Comparator
Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to \< 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
Placebo Peramivir, administered intravenously.
To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza.
Time to alleviation of clinical symptoms in adolescents and adults with uncomplicated acute influenza measured from patient reported study diaries.
Time frame: 14 Days
To evaluate the safety and tolerability of peramivir administered intravenously
To evaluate time to resolution of fever in response to treatment. To evaluate changes in influenza virus titer in nasal and pharyngeal samples (viral shedding) in response to treatment. To evaluate secondary clinical outcomes and changes in virus susceptibility to neuraminidase inhibitors in response to treatment.
Time frame: 14 Days
This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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BioCryst Pharmaceuticals