Trials / Terminated
TerminatedNCT00958776
A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza
A Phase 3, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Serious Influenza
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 405 (actual)
- Sponsor
- BioCryst Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peramivir+SOC | * Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. * Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. |
| DRUG | Placebo+SOC | Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2012-11-01
- Completion
- 2013-10-01
- First posted
- 2009-08-13
- Last updated
- 2015-02-12
- Results posted
- 2015-02-12
Locations
196 sites across 23 countries: United States, Argentina, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Czechia, Germany, Hungary, India, Israel, Latvia, Lebanon, Peru, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00958776. Inclusion in this directory is not an endorsement.