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Sponsored by: |
BioCryst Pharmaceuticals |
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Information provided by: | BioCryst Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00705406 |
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Condition | Intervention | Phase |
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Acute, Uncomplicated Human Influenza |
Drug: Peramivir Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza |
Estimated Enrollment: | 320 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Peramivir 600 mg: Experimental
600 mg peramivir administered as bilateral 2mL intramuscular injection.
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Drug: Peramivir
600 mg peramivir administered as bilateral 2mL intramuscular injection
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Placebo: Placebo Comparator
Placebo (buffered diluent) administered as bilateral 2mL intramuscular injection.
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Drug: Placebo
Placebo (buffered diluent) administered as bilateral 2mL intramuscular injection.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julie Daves | 919-859-7918 | jdaves@biocryst.com |
Contact: Connie Morris | 919-859-7911 | cmorris1@biocryst.com |
Responsible Party: | BioCryst Pharmaceuticals ( Connie Morris ) |
Study ID Numbers: | BCX1812-212 |
Study First Received: | June 24, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00705406 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: National Health and Medical Research Council; New Zealand: Medsafe; South Africa: Medicines Control Council |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |