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Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza

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ClinicalTrials.gov Identifier: NCT02635724
Recruitment Status : Completed
First Posted : December 21, 2015
Results First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Peramivir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Peramivir

Arm Intervention/treatment
Experimental: Peramivir
Single dose 600 mg IV injection
Drug: Peramivir
Other Name: Rapivab




Primary Outcome Measures :
  1. Safety and Tolerability, as Measured by the Number of Adverse Events. [ Time Frame: 14 days ]
    Safety was evaluated through assessment of Adverse Events (AEs).


Secondary Outcome Measures :
  1. Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion [ Time Frame: up to 3 hours post peramivir infusion ]
    Up to 3 plasma samples will be drawn, where possible: immediately following infusion, 30 mins to 1 hr post-infusion & 1 to 3 hrs post-infusion. Maximum concentration (Cmax), area under the concentration vs. time curve (AUC) from time 0 to 1 hour (AUC0-1), AUC from time 0 to 1.5 hours (AUC0-1.5), and AUC from time 0 to the last measurable time point (AUC0-last) were calculated in Phoenix® WinNonlin® v6.4. No summary statistics were reported due to the variation in the infusion time and sampling times.

  2. Time to Resolution of Fever [ Time Frame: 14 days ]
    Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had an oral temperature < 37.4°C/99.4°F oral and no antipyretic medications were taken for at least 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data. Subjects who did not have resolution of fever were censored at the time of their last non-missing post-baseline temperature assessment.

  3. Time to Resolution of Influenza Symptoms [ Time Frame: 14 days ]
    Subjects were asked to provide an assessment of 7 influenza symptoms (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) on a 4-point severity scale (0, absent; 1, mild; 2, moderate; 3, severe) beginning at Screening then twice daily beginning on Day 1 through to Day 13, and prior to the subject's clinic visit on Day 14. Once all symptoms were scored a 0 or 1 for at least 48 hours, recordings were discontinued. The time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 21.5-hour period (24 hours less 10%), where all symptoms of influenza were recorded as none (0) or mild (1), was estimated overall and for each age group using the Kaplan-Meier method.

  4. Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment. [ Time Frame: Change from baseline assessed on days 3, 7 and 14. ]
    Change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group.

  5. Time to Reduction in Viral Shedding [ Time Frame: 14 days ]
    Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.

  6. Incidence of Influenza-related Complications [ Time Frame: 14 days ]
    Study personnel evaluated the subject at Screening and Days 3, 7, and 14 for the presence of clinical signs and/or symptoms of the following influenza-related complications: Sinusitis, Otitis media, Bronchitis & Pneumonia. Note that subjects with clinical signs and/or symptoms consistent with bacterial infections, including otitis media, bronchitis, sinusitis, and/or pneumonia at Screening, were not eligible for enrollment in this study. If an influenza-related complication was suspected, then a targeted physical examination was to be conducted to confirm the presence or absence of the influenza-related complication.

  7. Time to Return to Usual Activities [ Time Frame: 14 days ]
    The ability to perform usual daily activities was assessed on a VAS (Visual Analogue Scale), where 0 indicates "unable to perform usual activities at all" and 10 indicates "able to perform usual activities.". The time to return to usual activities was the number of days from initiation of study drug until the subject recorded a rating of 10 (able to perform all usual activities fully) on the VAS; this was estimated for each age group and overall using the Kaplan-Meier method.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635724


Locations
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United States, Florida
Peramivir Investigational Site
Brooksville, Florida, United States
Peramivir Investigational Site
Lakeland, Florida, United States
Peramivir Investigational Site
Miami, Florida, United States
Peramivir Investigational Site
Saint Petersburg, Florida, United States
Peramivir Investigational Site
Tampa, Florida, United States
United States, Indiana
Peramivir investigative site
Indianapolis, Indiana, United States
United States, Michigan
Peramivir investigative site
Detroit, Michigan, United States
United States, Ohio
Peramivir Investigational Site
Dayton, Ohio, United States
United States, Pennsylvania
Peramivir investigative site
Smithfield, Pennsylvania, United States
United States, Texas
Peramivir Investigational Site
Houston, Texas, United States
Peramivir Investigative Site
San Antonio, Texas, United States
Peramivir investigative site
Splendora, Texas, United States
United States, Utah
Peramivir Investigational Site
Draper, Utah, United States
Peramivir Investigational Site
Salt Lake City, Utah, United States
Peramivir investigative site
South Jordan, Utah, United States
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
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Principal Investigator: Carol Clark, MD Prof., Dept. of Emergency Medicine, Oakland University, William Beaumont School of Medicine, Royal Oak, MI
  Study Documents (Full-Text)

Documents provided by BioCryst Pharmaceuticals:
Study Protocol  [PDF] August 9, 2017
Statistical Analysis Plan  [PDF] June 13, 2018

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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02635724    
Other Study ID Numbers: BCX1812-306
First Posted: December 21, 2015    Key Record Dates
Results First Posted: March 23, 2021
Last Update Posted: March 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BioCryst Pharmaceuticals:
Acute uncomplicated
Elderly
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Peramivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action