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| Sponsor: | BioCryst Pharmaceuticals |
|---|---|
| Information provided by: | BioCryst Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00705406 |
Purpose
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Peramivir 600 mg: Experimental
600 mg peramivir administered as bilateral 2mL intramuscular injection.
|
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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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 123 Study Locations
More Information
| Responsible Party: | BioCryst Pharmaceuticals ( Connie Morris ) |
| Study ID Numbers: | BCX1812-212 |
| Study First Received: | June 24, 2008 |
| Last Updated: | May 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00705406 History of Changes |
| 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 |
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Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |