Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza
This study has been designed as a randomized, double-blind, controlled, study to evaluate the
efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg)
versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute
serious or potentially life threatening influenza. Study treatments will be provided for up
to 5 consecutive days.
A Multinational Phase III Study of CS-8958 (MARVEL)
Daiichi Sankyo Co., Ltd.
The primary objective of this study is to confirm the efficacy of CS-8958 administered as a
single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir
phosphate using the time to alleviation of influenza illness. For safety evaluation,
between-group comparisons will be made with regard to incidence of adverse events and other
In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated
based on the efficacy and safety of single inhaled low or high dose.
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