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Withdrawn NCT01224795

A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

Conditions: Influenza

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Sponsor: BioCryst Pharmaceuticals

Location: Birmingham Alabama

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Male and non-pregnant female subjects age ≥12 years. * Test positive for influenza A or B by Rapid Antigen Test (RAT) performed with a commercially available test on an adequate anterior nasal specimen in accordance with the manufacturer's instructions. * Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity. * Presence of at least one constitutional symptom (myalgia \[aches and pains\], headache,feverishness, or fatigue) of at least moderate severity. * Onset of symptoms no more than 36 hours before presentation for screening. * Written informed consent/assent. Exclusion Criteria: * Women who are pregnant or breast-feeding. * Employees of the study site, or immediate family members of study site employees. * Presence of clinically significant signs of acute respiratory distress. * History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma. * History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months. * History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01224795). StuddyBuddy aggregates publicly available trial information.