InfluenzaPhase 3NCT00610935

Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza

A Phase 3 study testing Peramivir in people with Influenza, run by BioCryst Pharmaceuticals at 96 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Influenza
What is being tested?: Peramivir
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 96 sitesUnited States
Study dates: Jan 2008to Feb 2008
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and non-pregnant female subjects age ≥18 years.
A positive Influenza A and/or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one-hour.
Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity.
Onset of symptoms no more than 48 hours before presentation for screening.
Written informed consent.

Who cannot join

Women who are pregnant or breast-feeding.
Presence of clinically significant signs of acute respiratory distress.
History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma (See section 15.2).
History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.
History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min).

Show all 19Show fewer

Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.
Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
Currently receiving treatment for viral hepatitis B or viral hepatitis C.
Presence of known HIV infection with a CD4 count <350 cell/mm3.
Current therapy with oral warfarin or other systemic anticoagulant.
Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
Immunized against influenza with inactivated virus vaccine within the previous 14 days.
Receipt of any intramuscular injection within the previous 14 days.
History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.
Participation in a study of any investigational drug or device within the last 30 days.

Trial locations and contacts

96 sites in 1 country.

City, postcode or hospital

96 sites in 1 country

United States96 sites

NuLife Clinical Research, Inc.
Anaheim, California, 92805
Integrated Medical Research PC
Ashland, Oregon, 97520
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808
DiscoveResearch Inc.
Beaumont, Texas, 77701
Northwest Clinical Research Center
Bellevue, Washington, 98004
Professional Clinical Research-Benzonia
Benzonia, Michigan, 49616
Impact Clinical Trials
Beverly Hills, California, 90211
Alpine Clinical Research Center
Boulder, Colorado, 80304
Clinical Research Department
Bozeman, Montana, 59715
Holston Medical Group, PC
Bristol, Tennessee, 37620
DiscoveResearch, Inc.
Bryan, Texas, 77802
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Professional Clinical Research, Inc.
Cadillac, Michigan, 49601
Community Medical Partners
Canfield, Ohio, 44406
Clinicos, LLC
Colorado Springs, Colorado, 80904
Parsons Avenue Medical Clinic
Columbus, Ohio, 43207
Intrinsic Research Data, Inc.
Corpus Christi, Texas, 78411
New England Center for Clinical Research, Inc.
Cranston, Rhode Island, 02920
Allergy/Immunology Research Center of North Texas
Dallas, Texas, 75230
Research Across America
Dallas, Texas, 75234
Medical Associates Clinic PC
Dubuque, Iowa, 52001
Physician Care PM
Edmond, Oklahoma, 73013
Health Sciences Research Center at Asthma & Allergy Associates P.C.
Elmira, New York, 14901
Med Investigations Incorporated
Fair Oaks, California, 95628
Prarie Fields Family Medicine, P.C
Fremont, Nebraska, 68025
Universal Biopharma Research Institute Inc.
Fresno, California, 93703
Research Center of Fresno, Inc
Fresno, California, 93726
Florida Research Network, LLC
Gainesville, Florida, 32605
Harmony Clinical, Inc.
Garden Grove, California, 92843
Paris View Family Practice
Greenville, South Carolina, 29601
Andras Koser
Greenville, South Carolina, 29615
Quick Care Medical
Hamilton, New Jersey, 08690
Kentucky Lung Clinic
Hazard, Kentucky, 41701
AGA Clinical Trials
Hialeah, Florida, 33012
Eastern Research
Hialeah, Florida, 33013
Century Clinical Research Inc
Holly Hill, Florida, 32117
West Houston Clinical Research Service
Houston, Texas, 77055
Dynamed Clinical Research, L.P.
Houston, Texas, 77070
Investigators Research Group, LLC
Indianapolis, Indiana, 46268
Professional Clinical Research-Interlochen
Interlochen, Michigan, 49643
Health Sciences Research Center
Ithaca, New York, 14850
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Office of Roger J. Miller, Jr., MD
Jacksonville, Florida, 32257
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Clopton Clinic
Jonesboro, Arkansas, 72401
Research Solutions, LLC
Jonesboro, Arkansas, 72401
Holston Medical Group, P.C.
Kingsport, Tennessee, 37660
Gulf Coast Research LLC
Lafayette, Louisiana, 70503
MD Now Medical Center
Lake Worth, Florida, 33463
DMI Healthcare Group
Largo, Florida, 33773
Allergy, Asthma, and Respiratory Care Medical Center
Long Beach, California, 90806
Longmont Clinic, P.C.
Longmont, Colorado, 80501
National Institute of Clinical Research
Los Angeles, California, 90017
Ohio Clinical Research LLC
Lyndhurst, Ohio, 44124
Well Pharma Medical Research, Corp.
Miami, Florida, 33143
Physical Express
Millbrook, Alabama, 36054
Kevin Adkins, MD
Mountain Home, Arkansas, 72653
Welborn Clinic Gateway
Newburgh, Indiana, 47630
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
Compass Research LLC
Orlando, Florida, 32806
Urgent Care of Green County
Owasso, Oklahoma, 74055
Center for Clinical Trials, LLC
Paramount, California, 90723
Pines Research, LLC
Pembroke Pines, Florida, 33028
HOPE Research Institute
Phoenix, Arizona, 85050
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15241
Quincy Medical Group
Quincy, Illinois, 62301
American Institute of Healthcare & Fitness
Raleigh, North Carolina, 27605
Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research
Richmond, Virginia, 23229
KMED Research
Saint Clair Shores, Michigan, 48081
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, 34769
Optimum Clinical Research
Salt Lake City, Utah, 84102
J. Lewis Research Inc
Salt Lake City, Utah, 84109
J. Lewis Research Inc. Foothill Family Clinic South
Salt Lake City, Utah, 84121
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121
Sun Research Institute
San Antonio, Texas, 78205
GSA Research
San Antonio, Texas, 78213
San Antonio Preventive and Diagnostic Medicine
San Antonio, Texas, 78229
San Diego Sports Medicine and Family Health Center
San Diego, California, 92120
Coastal Medical Research Group, Inc.
San Luis Obispo, California, 93405
Sandersville Family Practice Center
Sandersville, Georgia, 31082
Physicians Research Options, LLC
Saratoga Springs, Utah, 84045
Heart of America Research Institute
Shawnee Mission, Kansas, 66216
Byron Jackson
Shreveport, Louisiana, 71104
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303
Clinvest
Springfield, Missouri, 65807
American Medical Exams, P.A.
Topeka, Kansas, 66608
Alabama Family Medical Center
Tuscaloosa, Alabama, 35404
Warminster Medical Associates, PC
Warminster, Pennsylvania, 18974
Holston Medical Group
Weber City, Virginia, 24290
J. Lewis Research Inc. FirstMed
West Jordan, Utah, 84088
Palm Beach Research Center
West Palm Beach, Florida, 33409
Winchester, Patton, Burgess, PSC
Whitley City, Kentucky, 42653-0099
Heartland Research Associates, LLC
Wichita, Kansas, 67212

Other trials in United States

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.

Conditions: Influenza
Being tested: Peramivir, Placebo
Keywords: Influenza, Subjects with uncomplicated acute influenza
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
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.
PlaceboDrug
Single intramuscular injection

Study groups in NCT00610935
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo intramuscular injection Receives: Drug: Placebo
Peramivir	Experimental	Single intramuscular injection of 300mg peramivir Receives: Drug: Peramivir

What is being measured

The primary outcome is the main question the study is designed to answer.

The Time to Alleviation of Clinical Signs and Symptoms of Influenza
The primary efficacy endpoint was the time to alleviation of symptoms of influenza in subjects diagnosed with influenza, defined as the time from injection of study drug to the start of the time period when a subject had Alleviation of Symptoms. A subject had Alleviation of Symptoms if each of the seven symptoms of influenza (cough, sore throat, nasal obstruction, myalgia [aches and pains], headache, feverishness, and fatigue) as self-assessed and recorded in the subject diary were either absent or were present at no more than mild severity level and at this status for at least 21.5 hours (24 hours minus 10%). No statistical testing was performed.
Measured: Up to 14 days

Secondary outcomes (1)

To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
The 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. The differences between the treatment groups were planned to be evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID50/mL were obtained at interval visits after treatment. As the study was terminated prematurely, no statistical testing was performed on these data.
Measured: Change from baseline assessed on days 3, 5 and 9.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Feb 2008

First posted8 Feb 2008 (estimated)
Study startJan 2008
Primary completionFeb 2008
Study completionFeb 2008

Why it stopped: This study was terminated for administrative reasons.

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00610935
Sponsor's protocol ID: BCX1812 311
Other IDs: HHS # O100200700032C
Status last verified: Feb 2021
First submitted: 25 Jan 2008
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.
ClinicalTrials.gov ID: NCT00610935
Acronym / sponsor ID: BCX1812 311
Conditions: Influenza
Keywords: Influenza, Subjects with uncomplicated acute influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated for administrative reasons.
Enrolment: 82 participants (actual)
Lead sponsor: BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2008 (actual)
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 8 Feb 2008 (estimated)
Results: Posted 17 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo intramuscular injection
Peramivir	Experimental	Drug: PeramivirSingle intramuscular injection of 300mg peramivir

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and non-pregnant female subjects age ≥18 years.
A positive Influenza A and/or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one-hour.
Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity.

Key exclusion criteria (19 listed)

Women who are pregnant or breast-feeding.
Presence of clinically significant signs of acute respiratory distress.
History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma (See section 15.2).
History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.

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
PeramivirTo evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.	Drug	Peramivir
PlaceboSingle intramuscular injection	Drug	Placebo

Primary outcome

The Time to Alleviation of Clinical Signs and Symptoms of Influenza
Time frame: Up to 14 days
The primary efficacy endpoint was the time to alleviation of symptoms of influenza in subjects diagnosed with influenza, defined as the time from injection of study drug to the start of the time period when a subject had Alleviation of Symptoms. A subject had Alleviation of Symptoms if each of the seven symptoms of influenza (cough, sore throat, nasal obstruction, myalgia [aches and pains], headache, feverishness, and fatigue) as self-assessed and recorded in the subject diary were either absent or were present at no more than mild severity level and at this status for at least 21.5 hours (24 hours minus 10%). No statistical testing was performed.

1 secondary outcome

To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Time frame: Change from baseline assessed on days 3, 5 and 9.

Results and safety

Results posted to the registry on 17 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	25	24
Peramivir	57	54

Primary outcome: The Time to Alleviation of Clinical Signs and Symptoms of Influenza

Time frame: Up to 14 days. Median (95% Confidence Interval). Unit: hours

Measure	Placebo n = 24	Peramivir n = 55
Value	118.3 (81.3 to 175.5)	103.9 (81.7 to 126.8)

Population analysed: A total of 80 subjects met the criteria for inclusion in the ITTI population as defined by a positive PCR assay for influenza A or B from the nasopharyngeal specimen obtained prior to administration of study treatment. Seventy-nine of these were included in the primary efficacy analysis for whom data for time to symptom alleviation were available; There was insufficient data from one subject in the placebo group to enable determination of the Time to Alleviation of Symptoms.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Reports of TEAEs were collected from the time of study drug administration through to the follow-up period ending on Day 14.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	13 of 25 (52%)	0 of 25
Peramivir	0 of 57 (0%)	26 of 57 (45.6%)	0 of 57

Limitations and caveats (from the sponsor): The study was terminated at the discretion of the Sponsor after 82 of the planned 600 subjects were enrolled. The reason for study termination was to allow the Sponsor to focus development efforts on a more concentrated formulation which would also allow evaluation of higher doses of peramivir administered intramuscularly.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 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.

The record lists no contact. Use the official record to reach the sponsor.

96 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peramivir in people with Influenza, run by BioCryst Pharmaceuticals at 96 sites in United States.

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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 17 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 96 sites in United States. 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. Some participants in this study may receive a placebo. 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 17 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?

The Time to Alleviation of Clinical Signs and Symptoms of Influenza (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00610935.

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 17 Mar 2021.