Phase 3
N=74
Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02635724 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Safety and Tolerability, as Measured by the Number of Adverse Events. — 17; 9; 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Peramivir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioCryst Pharmaceuticals
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability, as Measured by the Number of Adverse Events. |
17; 9; 1; 5; 3; 0 | — |
| SECONDARY Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion |
42400; 68300; 64600; 30600; 53600; 54400 | — |
| SECONDARY Time to Resolution of Fever |
41.5; 29.3; 9.4 | — |
| SECONDARY Time to Resolution of Influenza Symptoms |
124.8; 114.5; 54.0 | — |
| SECONDARY Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment. |
4.50; 4.45; 4.70; -3.25; -3.00; -4.00 | — |
| SECONDARY Time to Reduction in Viral Shedding |
27; 15; 2; 13; 4; 0 | — |
| SECONDARY Incidence of Influenza-related Complications |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Time to Return to Usual Activities |
10.0; 12.1; 9.8 | — |
Summary
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.
Eligibility Criteria
Inclusion Criteria
- A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR
- 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 but ≤ 72-hours
Exclusion Criteria
- Women who plan to breast-feed for the first 48 hours after study drug administration
- 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
Data sourced from ClinicalTrials.gov (NCT02635724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.