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This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.
Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study. A series of Phase 1 studies in human volunteers was completed that provided safety and pharmacokinetic results that supported the initiation of this Phase 2 multinational, randomized, double-mask study that compared the antiviral efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. Because of the unique pharmacokinetic and pharmacodynamic properties of peramivir - a long terminal half life in plasma and an extended duration of binding to the neuraminidase enzyme - subjects were randomized in a 1:1:1 ratio to receive a single dose of one of three treatments: peramivir 150 mg, peramivir 300 mg, and placebo. Study drug was administered as one 2-mL intramuscular injection in each gluteal muscle (total of 4 mL, injected in divided doses). This multinational study was originally to be conducted at approximately 80 sites in the US and Canada. When enrollment during the North American influenza season of 2006-2007 did not achieve the target, the study was extended to sites in Australia, New Zealand, South Africa, and Hong Kong.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peramivir 150 mg | Experimental |
| |
| Peramivir 300 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peramivir 150 mg | Drug | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation of Symptoms (Kaplan-Meier Estimate) | Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed. | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of Fever | The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed. |
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Inclusion Criteria:
Age ≥18 years
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. However, this requirement is waived if the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening.
Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)
Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.
Females of childbearing potential must report one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Block, MD | Kentucky Pediatric/Adult Research | Principal Investigator |
| James Borders, MD | Central Kentucky Research Assoc, Inc | Principal Investigator |
| Robert Broker, MD | Hillcrest Family Practice | Principal Investigator |
| Paul Browstone, MD | Alpine Clinical Research Center | Principal Investigator |
| Jeffry Jacqmein, MD | Jacksonville Center For Clinical Research | Principal Investigator |
| Isaac Marcadis, MD | Palm Beach Research Center | Principal Investigator |
| Mark Stich, MD | Jacksonville Center For Clinical Research | Principal Investigator |
| George Atiee, MD | GSA Research | Principal Investigator |
| Joe Blumenau, MD | Research Across America | Principal Investigator |
| John Champlin, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | United States | ||
| Clopton Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). |
| FG001 | Peramivir 150 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Peramivir 300 mg | Drug | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
|
|
| Placebo | Drug | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). |
|
| Up to 14 days |
| Time to Resumption of Ability to Perform Usual Activities | The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment. | Up to 14 days |
| Change From Baseline to Day 2 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 24 hours after treatment |
| Change From Baseline to Day 3 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 48 hours after treatment |
| Change From Baseline to Day 5 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 96 hours after treatment |
| Change From Baseline to Day 9 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 192 hours after treatment |
| Medical Center |
| Principal Investigator |
| Shane Christensen, MD | J. Lewis Research, Inc. Foothill Family Clinic South | Principal Investigator |
| Steven Duckor, MD | Advanced Clinical Research Institute | Principal Investigator |
| Lewis Eirinberg, MD | Midwest Family Physicians | Principal Investigator |
| Milton K. Erman, MD | Pacific Sleep Medicine Services | Principal Investigator |
| Stanley Cohen, MD | Radiant Research | Principal Investigator |
| David L. Fried, MD | Omega Medical Research | Principal Investigator |
| Yury Furman, MD | Pacific Sleep Medicine Services, Inc. | Principal Investigator |
| Wayne Harper, MD | Wake Research Associates, LLC | Principal Investigator |
| Dan C Henry, MD | J. Lewis Research, Inc. Foothill Family Clinic | Principal Investigator |
| John M. Hill, MD | University Clinical Research-Deland, LLC | Principal Investigator |
| Veryl Hodges, DO | Clopton Clinic | Principal Investigator |
| Reuben Holland, III, MD | Clinical Research Center | Principal Investigator |
| William Jennings, MD | Radiant Research San Antonio | Principal Investigator |
| James Edmond Kelaher, MD,MPH | Baylor Clinic-Baylor College of Medicine | Principal Investigator |
| Allan Kelly, MD | Hermitage Medicentres | Principal Investigator |
| Ben Lasko, MD | Manna Research | Principal Investigator |
| Mark Leber, MD | The Brooklyn Hospital Center | Principal Investigator |
| Larissa Lim, MD | Florida Medical Research Institute | Principal Investigator |
| Alain Martel, MD | Clinique medicale des Campus | Principal Investigator |
| Dennis Mikolich, MD | Paragon Clinical Research, Inc. | Principal Investigator |
| Julie Mullen, MD | Sterling Research Group, LTD. | Principal Investigator |
| David Parenti, MD | George Washington University | Principal Investigator |
| Monica Pierson, MD | Radiant Research | Principal Investigator |
| Robert Poirier, MD | Barnes-Jewish Hospital Emergency Department | Principal Investigator |
| Ivan Rarick, MD | Benchmark Research | Principal Investigator |
| Dennis Riff, MD | Advanced Clinical Research Institute | Principal Investigator |
| Q Rizvi, MD | Castledowns Medicentre | Principal Investigator |
| Michael Rokeach, MD | Pacific Sleep Medicine Services | Principal Investigator |
| Rawle Seupaul, MD | Wishard Hospital | Principal Investigator |
| Daniel Shu, MD | Gain Medical Research Centre | Principal Investigator |
| Steve Sitar, MD | Orange County Clinical Trials | Principal Investigator |
| Kirk Stiffler, MD | Summa Emergency Associates Inc. | Principal Investigator |
| Guy Tellier, MD | Omnispec clinical research Inc | Principal Investigator |
| Michael Warren, MD | Research Across America at Oyster Point Family Health Center | Principal Investigator |
| Randall Watson, MD | J. Lewis Research, Inc./Southwest Family Medicine | Principal Investigator |
| John Michael Wise, MD | Bozeman Urgent Care Center | Principal Investigator |
| Chivers Woodruff, Jr., MD | Radiant Research | Principal Investigator |
| Bruce Berwald, MD | Radiant Research | Principal Investigator |
| Frank Maggiacomo, DO | New England Center for Clinical Research, Inc | Principal Investigator |
| Barry Packman, MD | Radiant Research | Principal Investigator |
| Sheila Rodstein, MD | Radiant Research, Minneapolis | Principal Investigator |
| Bernardo Ng, MD | Pacific Sleep Medicines Service | Principal Investigator |
| Gerardo Losoya, MD | Towngate Plaza Medical Center | Principal Investigator |
| Francis X. Burch, MD | Radiant Research-San Antonio Northeast | Principal Investigator |
| John P. Delgado, MD | Integrated Medical Research, PC | Principal Investigator |
| Edward Fein, MD | Pulmonary & Critical Care Associates | Principal Investigator |
| Bruce D. Forney, MD | Alliance Medical Center | Principal Investigator |
| James E. Greenwald, MD | Medex Healthcare Research, Inc. | Principal Investigator |
| Robert Hudrick, DO | University of Medicine & Dentistry of New Jersey | Principal Investigator |
| Robert Jeanfreau, MD | Benchmark Research | Principal Investigator |
| Robert Kaufmann, MD | Georgia Clinical Research | Principal Investigator |
| Sy Lam, MD | Calgary West Medical Centre Clinical Studies | Principal Investigator |
| Keith S. Reisinger, MD, MPH | Primary Physicians Research, Inc | Principal Investigator |
| Keith S. Reisinger, MD, MPH | Family Practice Medical Associates South | Principal Investigator |
| Earl Martin, MD | Dynamed Clinical Research | Principal Investigator |
| Jean-Sebastien Gauthier, MD | Q & T Research Inc. | Principal Investigator |
| Jeffrey Rosen, MD | Clinical Research of Southern Florida | Principal Investigator |
| Gerald Burns, MD | New Orleans Medical | Principal Investigator |
| Stewart Behiel, MD | Belvedere Medicentre | Principal Investigator |
| Giuseppe D'Ignazio, MD | Source Unique Clinic | Principal Investigator |
| Indravadan Dattani, MD | Prairie Clinical | Principal Investigator |
| Roy A. Gritter, MD | RJA Medicentres | Principal Investigator |
| Balbir Chahal, MD | Balbir Chahal M.D. ,P.A. | Principal Investigator |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Orange County Clinical Trials | Anaheim | California | 92801 | United States |
| Medical Center | Carmichael | California | 95608 | United States |
| Pacific Sleep Medicines Service | El Centro | California | 92243 | United States |
| Advanced Clinical Research Institute | Orange | California | 92869 | United States |
| Benchmark Research | Sacramento | California | 95816 | United States |
| Pacific Sleep Medicine Services | San Diego | California | 92121 | United States |
| Pacific Sleep Medicine Services | San Francisco | California | 94105 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80304 | United States |
| George Washington Unviersity | Washington D.C. | District of Columbia | 20037 | United States |
| Clinical Research of Southern Florida | Coral Gables | Florida | 33134 | United States |
| University Clinical Research-Deland, LLC | DeLand | Florida | 32720 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32607 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Clinical Research Center | Sarasota | Florida | 34239 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Georgia Clinical Research | Atlanta | Georgia | 30308 | United States |
| Wishard Hospital | Indianapolis | Indiana | 46202 | United States |
| Radiant Research | Overland Park | Kansas | 66215 | United States |
| Kentucky Pediatric / Adult Research | Bardstown | Kentucky | 40004 | United States |
| Central Kentucky Research Assoc, Inc | Lexington | Kentucky | 40509 | United States |
| Benchmark Research | Metairie | Louisiana | 70006 | United States |
| Radiant Research, Minneapolis | Edina | Minnesota | 55435 | United States |
| Barnes-Jewish Hospital Emergency Department | St Louis | Missouri | 63110 | United States |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63124 | United States |
| Radiant Research | St Louis | Missouri | 63141 | United States |
| Bozeman Urgent Care Center | Bozeman | Montana | 59715 | United States |
| Alliance Medical Center | Alliance | Nebraska | 69301 | United States |
| Midwest Family Physicians | Omaha | Nebraska | 68154 | United States |
| UMDNJ | Cherry Hill | New Jersey | 08002 | United States |
| Pulmonary & Critical Care Associates | East Brunswick | New Jersey | 08816 | United States |
| Brooklyn Hospital Center | Brooklyn | New York | 11201 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Summa Health | Akron | Ohio | 44304 | United States |
| Sterling Research Group, LTD. | Cincinnati | Ohio | 45219 | United States |
| Integrated Medical Research, PC | Ashland | Oregon | 97520 | United States |
| Research Across America at Oyster Point Family Health Center | Lancaster | Pennsylvania | 17601 | United States |
| Radiant Research | Philadelphia | Pennsylvania | 19115 | United States |
| Primary Physicians Research, Inc | Pittsburgh | Pennsylvania | 15241 | United States |
| New England Center for Clinical Research, Inc | Cranston | Rhode Island | 02920 | United States |
| Paragon Clinical Research, Inc. | Cranston | Rhode Island | 02920 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Hillcrest Family Practice | Simpsonville | South Carolina | 29681 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Radiant Research | Dallas | Texas | 75235 | United States |
| Towngate Plaza Medical Center | Garland | Texas | 75041 | United States |
| Baylor Clinic-Baylor College of Medicine | Houston | Texas | 77030 | United States |
| GSA Research | San Antonio | Texas | 78213 | United States |
| Radiant Research-San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Radiant Research San Antonio | San Antonio | Texas | 78229 | United States |
| Balbir Chahal M.D. ,P.A | Tomball | Texas | 77375 | United States |
| Dynamed Clinical Research | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc. Foothill Family Clinic | 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./Southwest Family Medicine | West Jordan | Utah | 84084 | United States |
| Calgary West Medical Cnetre Clinical Studies | Calgary | Alberta | T3C3P1 | Canada |
| Belvedere Medicentre | Edmonton | Alberta | T5COA3 | Canada |
| Hermitage Medicentres | Edmonton | Alberta | T5COA3 | Canada |
| RJA Medicentres | Edmonton | Alberta | T5N2N8 | Canada |
| Castledowns Medicentre | Edmonton | Alberta | T5X3N5 | Canada |
| Gain Medical Centre | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Source Unique Clinic | Hawkesbury | Ontario | K6A1A1 | Canada |
| Manna Research | Toronto | Ontario | M9W4L6 | Canada |
| Omnispec Clinical Reasearch Inc | Mirabel | Quebec | J7J 2K8 | Canada |
| Clinique Medicale des Campus | Ste-Foy | Quebec | G1V4P9 | Canada |
| Prairie Clinical | Saskatoon | Saskatchewan | S7H 5M3 | Canada |
| FG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all subjects who received any dose of study drug. Subjects were analyzed according to the treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). |
| BG001 | Peramivir 150 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). |
| BG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index at Screening | Data were available for 114 participants in the placebo arm, 113 participants in the peramivir 150-mg arm, and 115 participants in the peramivir 300-mg arm. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Current Smoking Behavior at Randomization | Number | participants |
| ||||||||||||||||
| 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. Data were available for 111 participants in the placebo arm, 111 participants in the peramivir 150-mg arm, and 114 participants in the peramivir 300-mg arm. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Influenza Infection | Infection as measured by polymerase chain reaction (PCR) or serology. | Number | participants |
| |||||||||||||||
| Body Surface Area | Data were available for 114 participants in the placebo arm, 113 participants in the peramivir 150-mg arm, and 115 participants in the peramivir 300-mg arm. | Mean | Standard Deviation | m^2 |
|
| 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) | Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed. | The intent-to-treat infected (ITTI) population included all randomized subjects who received study drug and had proven influenza by culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Of the 318 subjects in the ITTI population, one subject had insufficient data to determine Time to Alleviation of Symptoms. | Posted | Median | 95% Confidence Interval | Hours | Up to 14 days |
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| Secondary | Time to Resolution of Fever | The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed. | The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | Hours | Up to 14 days |
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| Secondary | Time to Resumption of Ability to Perform Usual Activities | The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment. | The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | Days | Up to 14 days |
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| Secondary | Change From Baseline to Day 2 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized. | Posted | Median | Full Range | log10(TCID50/mL) | Baseline and approximately 24 hours after treatment |
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| Secondary | Change From Baseline to Day 3 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized. | Posted | Median | Full Range | log10(TCID50/mL) | Baseline and approximately 48 hours after treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 5 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized. | Posted | Median | Full Range | log10(TCID50/mL) | Baseline and approximately 96 hours after treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 9 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized. | Posted | Median | Full Range | log10(TCID50/mL) | Baseline and approximately 192 hours after treatment |
|
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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 | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). | 1 | 114 | 31 | 114 | ||
| EG001 | Peramivir 150 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). | 0 | 113 | 27 | 113 | ||
| EG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). | 1 | 115 | 25 | 115 | ||
| EG003 | Total | Total number of subjects who received at least 1 dose of study drug | 2 | 342 | 83 | 342 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis | Infections and infestations | MedDRA Version 9.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William P. Sheridan, MBBS | BioCryst Pharmaceuticals, Inc. | (919) 859-1302 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C414210 | peramivir |
Not provided
Not provided
Not provided
| 28 - 37 years old |
|
| 38 - 47 years old |
|
| 48 - 57 years old |
|
| ≥ 58 years old |
|
| Missing |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Nonsmoker |
|
| > 12 - 24 hours ago |
|
| > 24 - 36 hours ago |
|
| > 36 - 48 hours ago |
|
| Positive |
|
| Missing |
|
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
|
|
|
|
|
|
| OG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
|
|
|
| OG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
|
|
|
| OG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
|
|
|
| OG002 | Peramivir 300 mg | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
|
|
|