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Withdrawn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