Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
NCT ID: NCT02635724
Last Updated: 2021-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2015-12-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peramivir
Single dose 600 mg IV injection
Peramivir
Interventions
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Peramivir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least moderate severity (cough or rhinitis) and at least one constitutional symptom of at least moderate severity (myalgia \[aches and pains\], headache, feverishness, or fatigue)
* Influenza symptom onset \< 48 hours. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting \> 48-hours but ≤ 72-hours
Exclusion Criteria
* Subjects requiring hospital admission to treat medical condition(s) which could represent complications of influenza.
* Recent worsening of any chronic medical condition consistent with complications of influenza
* Current evidence of a bacterial infection requiring antibiotic treatment
18 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Carol Clark, MD
Role: PRINCIPAL_INVESTIGATOR
Prof., Dept. of Emergency Medicine, Oakland University, William Beaumont School of Medicine, Royal Oak, MI
Locations
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Peramivir Investigational Site
Brooksville, Florida, United States
Peramivir Investigational Site
Lakeland, Florida, United States
Peramivir Investigational Site
Miami, Florida, United States
Peramivir Investigational Site
St. Petersburg, Florida, United States
Peramivir Investigational Site
Tampa, Florida, United States
Peramivir investigative site
Indianapolis, Indiana, United States
Peramivir investigative site
Detroit, Michigan, United States
Peramivir Investigational Site
Dayton, Ohio, United States
Peramivir investigative site
Smithfield, Pennsylvania, United States
Peramivir Investigational Site
Houston, Texas, United States
Peramivir Investigative Site
San Antonio, Texas, United States
Peramivir investigative site
Splendora, Texas, United States
Peramivir Investigational Site
Draper, Utah, United States
Peramivir Investigational Site
Salt Lake City, Utah, United States
Peramivir investigative site
South Jordan, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BCX1812-306
Identifier Type: -
Identifier Source: org_study_id
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