Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
A Phase 3, Multicenter, Single-arm, Open-label, Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of Intravenous Peramivir in Elderly Subjects With Acute Uncomplicated Influenza Infection and in Subjects With Acute Uncomplicated Influenza Infection at Higher Risk for Influenza Complications
1 other identifier
interventional
74
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2015
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedResults Posted
Study results publicly available
March 23, 2021
CompletedMarch 23, 2021
February 1, 2021
2.3 years
December 17, 2015
February 5, 2021
February 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability, as Measured by the Number of Adverse Events.
Safety was evaluated through assessment of Adverse Events (AEs).
14 days
Secondary Outcomes (7)
Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion
up to 3 hours post peramivir infusion
Time to Resolution of Fever
14 days
Time to Resolution of Influenza Symptoms
14 days
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Change from baseline assessed on days 3, 7 and 14.
Time to Reduction in Viral Shedding
14 days
- +2 more secondary outcomes
Study Arms (1)
Peramivir
EXPERIMENTALSingle dose 600 mg IV injection
Interventions
Eligibility Criteria
You may qualify if:
- 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. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting \> 48-hours but ≤ 72-hours
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Peramivir Investigational Site
Brooksville, Florida, United States
Peramivir Investigational Site
Lakeland, Florida, United States
Peramivir Investigational Site
Miami, Florida, United States
Peramivir Investigational Site
St. Petersburg, Florida, United States
Peramivir Investigational Site
Tampa, Florida, United States
Peramivir investigative site
Indianapolis, Indiana, United States
Peramivir investigative site
Detroit, Michigan, United States
Peramivir Investigational Site
Dayton, Ohio, United States
Peramivir investigative site
Smithfield, Pennsylvania, United States
Peramivir Investigational Site
Houston, Texas, United States
Peramivir Investigative Site
San Antonio, Texas, United States
Peramivir investigative site
Splendora, Texas, United States
Peramivir Investigational Site
Draper, Utah, United States
Peramivir Investigational Site
Salt Lake City, Utah, United States
Peramivir investigative site
South Jordan, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BioCryst Pharmaceuticals Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Carol Clark, MD
Prof., Dept. of Emergency Medicine, Oakland University, William Beaumont School of Medicine, Royal Oak, MI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2015
First Posted
December 21, 2015
Study Start
December 1, 2015
Primary Completion
April 1, 2018
Study Completion
September 1, 2018
Last Updated
March 23, 2021
Results First Posted
March 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share