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| ID | Type | Description | Link |
|---|---|---|---|
| HHS # O100200700032C | Registry Identifier | U.S. Department of Health & Human Services |
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This study was terminated for administrative reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo intramuscular injection |
|
| Peramivir | Experimental | Single intramuscular injection of 300mg peramivir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peramivir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Express | Millbrook | Alabama | 36054 | United States | ||
| Alabama Family Medical Center |
Subjects were centrally randomized in a ratio of 2:1 to a single dose of IM peramivir 300 mg or placebo, in accordance with a computer-generated randomization schedule prepared by a non-study statistician. Each subject's assignment to treatment was stratified according to smoking status and RAT test for influenza A or B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo intramuscular injection |
| FG001 | Peramivir | Single intramuscular injection of 300mg peramivir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2007 |
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| Placebo | Drug | Single intramuscular injection |
|
| Change from baseline assessed on days 3, 5 and 9. |
| Tuscaloosa |
| Alabama |
| 35404 |
| United States |
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States |
| Clopton Clinic | Jonesboro | Arkansas | 72401 | United States |
| Research Solutions, LLC | Jonesboro | Arkansas | 72401 | United States |
| Kevin Adkins, MD | Mountain Home | Arkansas | 72653 | United States |
| NuLife Clinical Research, Inc. | Anaheim | California | 92805 | United States |
| Impact Clinical Trials | Beverly Hills | California | 90211 | United States |
| Associated Pharmaceutical Research Center, Inc. | Buena Park | California | 90620 | United States |
| Med Investigations Incorporated | Fair Oaks | California | 95628 | United States |
| Universal Biopharma Research Institute Inc. | Fresno | California | 93703 | United States |
| Research Center of Fresno, Inc | Fresno | California | 93726 | United States |
| Harmony Clinical, Inc. | Garden Grove | California | 92843 | United States |
| Allergy, Asthma, and Respiratory Care Medical Center | Long Beach | California | 90806 | United States |
| National Institute of Clinical Research | Los Angeles | California | 90017 | United States |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | United States |
| San Diego Sports Medicine and Family Health Center | San Diego | California | 92120 | United States |
| Coastal Medical Research Group, Inc. | San Luis Obispo | California | 93405 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80304 | United States |
| Clinicos, LLC | Colorado Springs | Colorado | 80904 | United States |
| Longmont Clinic, P.C. | Longmont | Colorado | 80501 | United States |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | United States |
| AGA Clinical Trials | Hialeah | Florida | 33012 | United States |
| Eastern Research | Hialeah | Florida | 33013 | United States |
| Century Clinical Research Inc | Holly Hill | Florida | 32117 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Office of Roger J. Miller, Jr., MD | Jacksonville | Florida | 32257 | United States |
| MD Now Medical Center | Lake Worth | Florida | 33463 | United States |
| DMI Healthcare Group | Largo | Florida | 33773 | United States |
| Well Pharma Medical Research, Corp. | Miami | Florida | 33143 | United States |
| Compass Research LLC | Orlando | Florida | 32806 | United States |
| Pines Research, LLC | Pembroke Pines | Florida | 33028 | United States |
| Wilker/Powers Center for Clinical Studies | Saint Cloud | Florida | 34769 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Sandersville Family Practice Center | Sandersville | Georgia | 31082 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Investigators Research Group, LLC | Indianapolis | Indiana | 46268 | United States |
| Welborn Clinic Gateway | Newburgh | Indiana | 47630 | United States |
| Medical Associates Clinic PC | Dubuque | Iowa | 52001 | United States |
| Heart of America Research Institute | Shawnee Mission | Kansas | 66216 | United States |
| American Medical Exams, P.A. | Topeka | Kansas | 66608 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67212 | United States |
| Kentucky Lung Clinic | Hazard | Kentucky | 41701 | United States |
| Winchester, Patton, Burgess, PSC | Whitley City | Kentucky | 42653-0099 | United States |
| Gulf Coast Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| Gulf Coast Research LLC | Lafayette | Louisiana | 70503 | United States |
| Byron Jackson | Shreveport | Louisiana | 71104 | United States |
| Professional Clinical Research-Benzonia | Benzonia | Michigan | 49616 | United States |
| Professional Clinical Research, Inc. | Cadillac | Michigan | 49601 | United States |
| Professional Clinical Research-Interlochen | Interlochen | Michigan | 49643 | United States |
| KMED Research | Saint Clair Shores | Michigan | 48081 | United States |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| Clinical Research Department | Bozeman | Montana | 59715 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Prarie Fields Family Medicine, P.C | Fremont | Nebraska | 68025 | United States |
| Quick Care Medical | Hamilton | New Jersey | 08690 | United States |
| Health Sciences Research Center at Asthma & Allergy Associates P.C. | Elmira | New York | 14901 | United States |
| Health Sciences Research Center | Ithaca | New York | 14850 | United States |
| American Institute of Healthcare & Fitness | Raleigh | North Carolina | 27605 | United States |
| Community Medical Partners | Canfield | Ohio | 44406 | United States |
| Parsons Avenue Medical Clinic | Columbus | Ohio | 43207 | United States |
| Ohio Clinical Research LLC | Lyndhurst | Ohio | 44124 | United States |
| Physician Care PM | Edmond | Oklahoma | 73013 | United States |
| Urgent Care of Green County | Owasso | Oklahoma | 74055 | United States |
| Integrated Medical Research PC | Ashland | Oregon | 97520 | United States |
| Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | 15241 | United States |
| Warminster Medical Associates, PC | Warminster | Pennsylvania | 18974 | United States |
| New England Center for Clinical Research, Inc. | Cranston | Rhode Island | 02920 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Paris View Family Practice | Greenville | South Carolina | 29601 | United States |
| Andras Koser | Greenville | South Carolina | 29615 | United States |
| Hillcrest Clinical Research, LLC | Simpsonville | South Carolina | 29681 | United States |
| S. Carolina Pharmaceutical Research | Spartanburg | South Carolina | 29303 | United States |
| Holston Medical Group, PC | Bristol | Tennessee | 37620 | United States |
| Holston Medical Group, P.C. | Kingsport | Tennessee | 37660 | United States |
| DiscoveResearch Inc. | Beaumont | Texas | 77701 | United States |
| DiscoveResearch, Inc. | Bryan | Texas | 77802 | United States |
| Intrinsic Research Data, Inc. | Corpus Christi | Texas | 78411 | United States |
| Allergy/Immunology Research Center of North Texas | Dallas | Texas | 75230 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| West Houston Clinical Research Service | Houston | Texas | 77055 | United States |
| Dynamed Clinical Research, L.P. | Houston | Texas | 77070 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| GSA Research | San Antonio | Texas | 78213 | United States |
| San Antonio Preventive and Diagnostic Medicine | San Antonio | Texas | 78229 | United States |
| Optimum Clinical Research | Salt Lake City | Utah | 84102 | United States |
| J. Lewis Research Inc | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research Inc. Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research, Inc. | Salt Lake City | Utah | 84121 | United States |
| Physicians Research Options, LLC | Saratoga Springs | Utah | 84045 | United States |
| J. Lewis Research Inc. FirstMed | West Jordan | Utah | 84088 | United States |
| Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research | Richmond | Virginia | 23229 | United States |
| Holston Medical Group | Weber City | Virginia | 24290 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| ITTI Population | Intent to treat - infected (ITTI) population included all subjects who were randomized, received at least one injection of study drug, and had proven influenza infection by at least one of the following assessments performed on a Screening/Baseline sample: positive PCR assay or positive viral culture for Influenza A or B. |
|
| ITT Population | Intent to treat (ITT) population included all randomized subjects for whom data were analyzed in the respective randomized treatment groups. The ITT population = Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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The ITT population included all randomized subjects for whom data were analyzed in the respective randomized treatment groups. The ITT population was the primary population for analyses of demography and subject accountability as well as safety.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo intramuscular injection |
| BG001 | Peramivir | Single intramuscular injection of 300mg peramivir |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Current Smoking Behavior at Randomization | Number | participants |
| ||||||||||||||||
| Influenza PCR Results | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | hours | Up to 14 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | The Intent To Treat Infected population (ITTI) population included all subjects who were randomized, received study drug, and had confirmed influenza A and/or B by primary viral culture or PCR. | Posted | Median | Full Range | influenza viral titer - log10 TCID50/mL | Change from baseline assessed on days 3, 5 and 9. |
|
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Reports of TEAEs were collected from the time of study drug administration through to the follow-up period ending on Day 14.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo intramuscular injection | 0 | 25 | 0 | 25 | 13 | 25 |
| EG001 | Peramivir | Single intramuscular injection of 300mg peramivir | 0 | 57 | 0 | 57 | 26 | 57 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope Vasovagal | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urine Protein Present | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BioCryst Pharmaceuticals Inc | +1 919-859-1302 | clinicaltrials@biocryst.com |
| Feb 24, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C414210 | peramivir |
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| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-smoker |
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| Influenza A (H1N1) |
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| Influenza A (H3N2) |
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| Influenza A (IND) |
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| Influenza B |
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| Influenza A and B |
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| Participants |
|
|