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Sponsored by: |
BioCryst Pharmaceuticals |
Information provided by: | BioCryst Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00453999 |
This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.
Condition | Intervention | Phase |
Influenza |
Drug: Peramivir |
Phase II |
MedlinePlus related topics: | Flu |
ChemIDplus related topics: | Oseltamivir Tamiflu BCX 1812 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing the Efficacy and Safety of Peramivir Administered Intravenously Once Daily Versus Oseltamivir Administered Orally Twice Daily in Adults With Acute Serious or Potentially Life-Threatening Influenza |
Estimated Enrollment: | 120 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment, or
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Drug: Peramivir
200mg in 100ml of solution 2 times a day
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2: Experimental
Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL), or
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Drug: Peramivir
2: Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL), or
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3: Experimental
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
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Drug: Peramivir
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
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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:
Show 84 Study Locations |
BioCryst Pharmaceuticals |
Responsible Party: | Biocryst Pharmaceuticals, Inc. ( Amy McCullough/ Director , Clinical Development ) |
Study ID Numbers: | BCX1812-201 |
First Received: | March 27, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00453999 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Human Research Ethics Committee; Hong Kong: Department of Health; New Zealand: Institutional Review Board; Singapore: Health Sciences Authority; South Africa: Medicines Control Council |
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