InfluenzaPhase 3NCT02369159
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
A Phase 3 study testing Peramivir and Oseltamivir in people with Influenza, run by BioCryst Pharmaceuticals at 10 sites in 2 countries.
Trial summary
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 0 days to 17 years
- Conditions the study is for
- Influenza
- What is being tested?
- Peramivir and Oseltamivir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 11 Mar 2015to 14 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by PCR or Rapid Antigen Test
- Onset of symptoms no more than 72 hours before presentation for screening for subjects < 2 years old.
Who cannot join
- Pregnant or breast-feeding females
- Development of symptoms while hospitalized
- Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications
- Presence of immunocompromised status
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Peramivir investigative site
Dayton, Ohio
Peramivir investigative site
Draper, Utah
Peramivir Investigative Site
Houston, Texas
Peramivir investigative site
Salt Lake City, Utah
Peramivir investigative site
San Antonio, Texas
Peramivir Investigative Site
Shreveport, Louisiana
Peramivir investigative site
Smithfield, Pennsylvania
Peramivir investigative site
South Jordan, Utah
Peramivir investigative site
Splendora, Texas
About this study
Official title: A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.
- Conditions
- Influenza
- Being tested
- Peramivir, Oseltamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeramivirDrug
OseltamivirDrug
| Study group | Role | What they receive |
|---|---|---|
| Peramivir (IV) | Experimental | Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes.
* Subjects ≥12 years will receive a dose of 600 mg.
* Subjects <12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg).
* Subjects < 6 months will receive a dose of 8 mg/kg. Receives: Drug: Peramivir |
| Oseltamivir | Active comparator | Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days.
* Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days).
* Subjects < 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days). Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Safety evaluation included assessment of Adverse Events (AEs).
Measured: 14 days
Secondary outcomes (6)
Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.
Measured: up to 6 hours post peramivir infusion
Time to Resolution of Fever
Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of < 99.4°F or an axillary temperature of < 98.4°F and no antipyretic medications were taken for ≥ 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.
Measured: 14 days
Time to Resolution of Influenza Symptoms
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Measured: 14 days
Time to Reduction in Viral Shedding
Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.
Measured: 14 days
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
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.
Measured: Change from baseline assessed on days 3, 7 and 14.
Influenza-Related Complications Assessment.
The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start11 Mar 2015
- Primary completion28 Oct 2019
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Vanchiere, MD, PhD, Principal investigator, Chief, Pediatric Infectious Diseases, Louisiana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369159
- Sponsor's protocol ID
- BCX1812-305
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2015
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT02369159
- Acronym / sponsor ID
- BCX1812-305
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peramivir (IV) | Experimental | Drug: PeramivirSubjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes. * Subjects ≥12 years will receive a dose of 600 mg. * Subjects <12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg). * Subjects < 6 months will receive a dose of 8 mg/kg. |
| Oseltamivir | Active comparator | Drug: OseltamivirSubjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days. * Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days). * Subjects < 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days). |
Who may qualify
- Ages
- 0 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by PCR or Rapid Antigen Test
- Onset of symptoms no more than 72 hours before presentation for screening for subjects < 2 years old.
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding females
- Development of symptoms while hospitalized
- Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications
- Presence of immunocompromised status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peramivir | Drug | Peramivir (IV) |
| Oseltamivir | Drug | Oseltamivir |
Primary outcome
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Time frame: 14 days
Safety evaluation included assessment of Adverse Events (AEs).
6 secondary outcomes
Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
Time frame: up to 6 hours post peramivir infusion
Time to Resolution of Fever
Time frame: 14 days
Time to Resolution of Influenza Symptoms
Time frame: 14 days
Time to Reduction in Viral Shedding
Time frame: 14 days
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Time frame: Change from baseline assessed on days 3, 7 and 14.
Influenza-Related Complications Assessment.
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Vanchiere, MD, PhD principal investigator
Chief, Pediatric Infectious Diseases, Louisiana State University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peramivir and Oseltamivir in people with Influenza, run by BioCryst Pharmaceuticals at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.