Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HHS 0100200700032C | Other Grant/Funding Number | HHS-BARDA |
Not provided
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The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peramivir 600 mg | Experimental | 600 mg peramivir administered as bilateral 2-mL intramuscular injection. |
|
| Placebo | Placebo Comparator | Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peramivir | Drug | 600 mg peramivir administered as bilateral 2-mL intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation of Symptoms (Kaplan-Meier Estimate) | The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment. | Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Influenza Virus Shedding | Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5). | Baseline and Days 3, 4, 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Severity of Illness (Score*Hours) | A subject's severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized. The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Alabama Research, Inc. | Birmingham | Alabama | 35209 | United States | ||
| Greystone Medical Research, LLC |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. |
| FG001 | Peramivir 600 mg | Peramivir 600 mg administered as bilateral 2-mL intramuscular injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Placebo | Drug | Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. |
|
| Information collected predose on Day 1 and then once daily through Day 14 |
| Time to Resolution of Fever | Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours. | Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 |
| Incidence of Influenza-related Complications | Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study. | 14 days |
| Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50) | Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. | Baseline |
| Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50) | Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. | Baseline and up to 14 days |
| Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50) | Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug. | Baseline and up to 14 days |
| Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50) | Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug. | Baseline and up to 14 days |
| Birmingham |
| Alabama |
| 35242 |
| United States |
| NextCare Institute for Clinical Research | Phoenix | Arizona | 85016 | United States |
| Clopton Clinic | Jonesboro | Arkansas | 72401 | United States |
| NEA Clinic | Jonesboro | Arkansas | 72401 | United States |
| North Central Arkansas Medical Associates | Mountain Home | Arkansas | 72653 | United States |
| Impact Clinical Trials | Beverly Hills | California | 90211 | United States |
| Medcenter | Carmichael | California | 95608 | United States |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | United States |
| Coastal Medical Research Group, Inc. | San Luis Obispo | California | 93405 | United States |
| Alpine Research Center | Boulder | Colorado | 80304 | United States |
| 1st Allergy and Clinical Research Center | Centennial | Colorado | 80112 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States |
| DMI Research, Inc. | Pinellas Park | Florida | 33782 | United States |
| Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies | Saint Cloud | Florida | 34769 | United States |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | United States |
| Southeast Regional Research Group | Savannah | Georgia | 31406 | United States |
| The Kaufmann Clinic, Inc. | Woodstock | Georgia | 30188 | United States |
| Idaho Falls Infectious Diseases | Idaho Falls | Idaho | 83404 | United States |
| Dr. Arthur Davida | Bloomingdale | Illinois | 60108 | United States |
| Investigators Research Group, LLC | Indianapolis | Indiana | 46268 | United States |
| Medical Associates Clinic | Dubuque | Iowa | 52001 | United States |
| Heart of America Research | Shawnee | Kansas | 66218 | United States |
| Kentucky Lung Clinic | Hazard | Kentucky | 41701 | United States |
| Gulf Coast Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| Acadia Clinical Research | Bangor | Maine | 44401 | United States |
| Clarksburg Medical Center | Clarksburg | Maryland | 20871 | United States |
| Miray Medical Center | Brockton | Massachusetts | 02301 | United States |
| Detroit Receiving Hospital, UHC 6G | Detroit | Michigan | 48201 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| KMED Research | Saint Claire Shores | Michigan | 48081 | United States |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | United States |
| Bozeman Urgent Care Center | Bozeman | Montana | 59715 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Prairie Fields Family Medicine, P.C. | Fremont | Nebraska | 68025 | United States |
| Impact Clinical Trials, Las Vegas | Las Vegas | Nevada | 89106 | United States |
| United Medical Associates | Johnson City | New York | 13790 | United States |
| Twelve Corners Internal Medicine | Rochester | New York | 14618 | United States |
| Bland Clinic | Greensboro | North Carolina | 27401 | United States |
| Community Medical Associates, LLC | Canfield | Ohio | 44515 | United States |
| Advanced Health Care Services, Inc | Thornville | Ohio | 43076 | United States |
| Urgent Care of Green County, PLLC | Owasso | Oklahoma | 74055 | United States |
| Integrated Medical Research, PC | Ashland | Oregon | 97520 | United States |
| Pivotal Clinical Research, LLC | Souderton | Pennsylvania | 18964 | United States |
| New England Center for Clinical Research, Inc. | Cranston | Rhode Island | 02920 | United States |
| Notheast Clinical Research | Cumberland | Rhode Island | 02864 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Hillcrest Clinical Research, LLC | Simpsonville | South Carolina | 29681 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Holston Medical Group | Bristol | Tennessee | 37620 | United States |
| DiscoveResearch, Inc. | Bryan | Texas | 77802 | United States |
| Corpus Christi Family Wellness Center, Research Division | Corpus Christi | Texas | 78414 | United States |
| Allergy/Immunology Research Center of North Texas | Dallas | Texas | 75230 | United States |
| Towngate Plaza Medical Center | Garland | Texas | 75041 | United States |
| West Houston Clinical Research | Houston | Texas | 77055 | United States |
| Texas Medical Research Associates, LLC | San Antonio | Texas | 78238 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc., FirstMed | Salt Lake City | Utah | 84088 | United States |
| J. Lewis Research, Inc./Foothill Family Clinic South | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc./FirstMed East | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research, Inc./Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Dean Medical Center | Oregon | Wisconsin | 53575 | United States |
| Pacific Medical Centre Blacktown | Blacktown | New South Wales | 2148 | Australia |
| East Sydney Doctors | Darlinghurst | New South Wales | 2010 | Australia |
| Symbion Pathology | Hurtsville | New South Wales | 2220 | Australia |
| Peninsula Medical Centre | Umina | New South Wales | 2257 | Australia |
| Rivercity Private Hospital Specialist | Auchenflower | Queensland | 4066 | Australia |
| Caboolture Clinical Research Centre | Caboolture | Queensland | 4510 | Australia |
| Peninsula Specialist Centre | Kpparing | Queensland | 4021 | Australia |
| Health Services -University of Melbourne | Carlton | Victoria | 3053 | Australia |
| Athelstone Medical Clinic | Adelaide | 5076 | Australia |
| Trialworks Clinical Research Services | Brisbane | Australia |
| Dr Doongs Surgery | Burwood | Australia |
| Holdsworth House Medical Practice | Darlinghurst | Australia |
| Doctors of Ivanhoe, | Melbourne | Australia |
| Lung Institute of Western Australia, | Nedlands | Australia |
| Pitt Street Merrylands Medical Centre | Sydney | Australia |
| St George's Hospital | Christchurch | Christchurch | 4737 | New Zealand |
| Bairds Road Family Health Care | Rotorua | Rotorua | 3010 | New Zealand |
| Greenhithe Medical Centre | Auckland | New Zealand |
| Southern Clinical Trials Ltd | Christchurch | New Zealand |
| Caversham Medical Centre | Dunedin | New Zealand |
| Dr. Gillies | Rotorua | New Zealand |
| Hinemoa House Family Health Centre | Rotorua | New Zealand |
| Jsha Research | Bloemfontein | Bloemfontein | 9301 | South Africa |
| Nortje, MD | Goodwood | Capetown | 7460 | South Africa |
| Greenbury Medical Centre | Greenbury | Durban | 4068 | South Africa |
| Sebastian, MD | Silverglen | Durban | 4092 | South Africa |
| Quinta-Research | Bloemfontein | Free State | 9301 | South Africa |
| Wilhase, AC | Reigerpark | Gauteg | 1459 | South Africa |
| NHC Medical Centre | Bryanston | Gauteng | 2191 | South Africa |
| R. Dulabh, MD | Klipspruit West | Gauteng | 1812 | South Africa |
| DJW Navorsing | Noordheuwel | Krugersdorp | 1739 | South Africa |
| Pillay, MD | Verulam | KwaZulu-Natal | 4340 | South Africa |
| Vawda, Z.FA | Durban | KZ-Natal | 4091 | South Africa |
| le Clus, MD | Kempton Park | Pretoria | 1619 | South Africa |
| Sunnyside Medi-Clinic | Sunnyside Pretoria | Pretoria | 0132 | South Africa |
| Kaapzicht Centre | Cape Town | W. Cape | 7500 | South Africa |
| Syzygy SMO Intercare Medical and Dental Centre | Cape Town | W. Cape | 7530 | South Africa |
| Clinical Project Research SA (Pty) Ltd. | Worcester | W. Cape | 6850 | South Africa |
| Benmed Park Clinic | Benoni | 1501 | South Africa |
| Armansis Medical Centre | Brits | 0250 | South Africa |
| Cape Clinical Trial, Bishop Lavis Day Hospital | Cape Town | 7490 | South Africa |
| First House | Cape Town | 7941 | South Africa |
| Synapta Clinical Research Centre | Durban | 4001 | South Africa |
| Dr. Janari | Durban | South Africa |
| Dr. van Rensburg | eManzimtoti | 4126 | South Africa |
| Dr. Makan | Johannesburg | 1820 | South Africa |
| Newgate Centre | Johannesburg | South Africa |
| GCT Trials, Mercantile Hospital no 9 | Port Elizabeth | South Africa |
| Dr. Nel | Pretoria | 0083 | South Africa |
| Emmed Research | Pretoria | 0084 | South Africa |
| Dr. de Bruin | Pretoria | 9585 | South Africa |
| Westmed Clinical Trial Centre, Pretoria West Medicross Building | Pretoria | South Africa |
| Dr. Fouche | Roodepoort | 1724 | South Africa |
| Dr. de Villiers | Scottburgh | 4182 | South Africa |
| Dr. Bhorat | Soweto | 1818 | South Africa |
| Clinical Projects Research SA Ltd | Worcester | 6850 | South Africa |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. |
| BG001 | Peramivir 600 mg | Peramivir 600 mg administered as bilateral 2-mL intramuscular injection. |
| 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/Ethnicity, Customized | Participants may have been counted in more than 1 category; therefore, numbers may add up to more than the total number of participants. | Number | participants |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Estimated Time of Onset of Symptoms at Screening | Number | participants |
| ||||||||||||||||
| Initial Composite Symptom Score | Initial Composite Symptom Score is defined as the sum of the 7 symptoms of influenza initially recorded by the subject in the diary (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Rapid Antigen Test (RAT) Results | Positive influenza infection confirmed by PCR or virus culture. | Number | participants |
| |||||||||||||||
| Confirmed Influenza Infection Result | Number | participants |
| ||||||||||||||||
| Current Smoking Behavior | 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 | Time to Alleviation of Symptoms (Kaplan-Meier Estimate) | The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment. | The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR. | Posted | Median | 95% Confidence Interval | hours | Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Influenza Virus Shedding | Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5). | The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR. | Posted | Median | 95% Confidence Interval | log10(TCID50/mL) | Baseline and Days 3, 4, 9 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject's Severity of Illness (Score*Hours) | A subject's severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized. The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21. | The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR. | Posted | Median | Full Range | score*hours | Information collected predose on Day 1 and then once daily through Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Resolution of Fever | Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours. | The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR. | Posted | Median | 95% Confidence Interval | hours | Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Influenza-related Complications | Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study. | The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR. | Posted | Number | participants | 14 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50) | Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. | A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group. | Posted | Mean | Standard Error | nM | Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50) | Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. | A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir). | Posted | Mean | Standard Error | Fold Change from Baseline | Baseline and up to 14 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50) | Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug. | A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir. | Posted | Mean | Standard Error | nM | Baseline and up to 14 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50) | Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug. | A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir). | Posted | Mean | Standard Error | Fold Change from Baseline | Baseline and up to 14 days |
|
Treatment-emergent AEs included any AEs that occurred after treatment on Day 1 and up to and including the visit on Day 14.
Three of 405 subjects were randomized but did not receive treatment and were therefore not included in the safety population (N = 402; 202 in the Placebo group and 200 in the Peramivir 600 mg group).
Not provided
| 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 (buffered diluent) administered as bilateral 2-mL intramuscular injection. | 1 | 202 | 27 | 202 | ||
| EG001 | Peramivir 600 mg | Peramivir 600 mg administered as bilateral 2-mL intramuscular injection. | 0 | 200 | 31 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated Tuberculosis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
The majority of the subjects enrolled in this study with a laboratory confirmed influenza infection were infected with an influenza A/H1N1 virus containing an H275Y mutation associated with reduced susecptibility to peramivir and oseltamivir.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William P. Sheridan, MBBS | BioCryst Pharmaceuticals, Inc. | 919-859-1302 |
| ID | Term |
|---|---|
| C414210 | peramivir |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
| 12-24 h Ago |
|
| 24-36 h Ago |
|
| Data Missing |
|
| No data reported |
|
| Positive by Viral Culture Only |
|
| Positive by PCR and Viral Culture |
|
| Negative by PCR and Viral Culture |
|
| No Result/Sample |
|
| Nonsmoker |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
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| Participants |
|
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| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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