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Trial record 91 of 118 for:    oseltamivir

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

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ClinicalTrials.gov Identifier: NCT00453999
Recruitment Status : Completed
First Posted : March 29, 2007
Results First Posted : February 12, 2015
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Influenza
Interventions Drug: Peramivir 200 mg
Drug: Peramivir 400 mg
Drug: Oseltamivir
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Period Title: Overall Study
Started 45 46 46
Completed 40 41 43
Not Completed 5 5 3
Reason Not Completed
Adverse Event             1             2             1
Lost to Follow-up             0             1             1
Withdrawal by Subject             2             1             1
Subject Request             2             1             0
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir Total
Hide Arm/Group Description Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL) Total of all reporting groups
Overall Number of Baseline Participants 45 46 46 137
Hide Baseline Analysis Population Description
ITT Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 46 participants 46 participants 137 participants
56.9  (24.0) 58.5  (20.9) 62.0  (21.3) 59.2  (22.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 46 participants 137 participants
Female
25
  55.6%
26
  56.5%
25
  54.3%
76
  55.5%
Male
20
  44.4%
20
  43.5%
21
  45.7%
61
  44.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 46 participants 137 participants
White or Caucasian 23 21 20 64
Black or African American 8 14 12 34
Asian 13 10 13 36
American Indian or Alaska Native 0 0 0 0
Native Hawaiian or Other Pacific Islander 1 0 0 1
Other 0 1 1 2
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 45 participants 46 participants 46 participants 137 participants
163.0  (9.9) 161.6  (11.8) 168.4  (11.8) 164.4  (11.5)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 45 participants 46 participants 46 participants 137 participants
64.9  (19.8) 72.4  (22.9) 79.5  (22.7) 72.4  (22.5)
Duration of Illness at Randomization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 46 participants 137 participants
< 48 hours 31 32 31 94
>= 48 hours to <=72 hours 14 14 15 43
Initial Composite Symptom Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 45 participants 46 participants 46 participants 137 participants
12.7  (5.19) 12.2  (5.95) 12.3  (5.46) 12.4  (5.51)
[1]
Measure Description: Initial Composite Symptom Score is defined as the sum of the 7 symptoms of influenza recorded at the predose visit. (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 122 participants (39 in the Peramivir 200 mg group; 41 in the Peramivir 400 mg group; and 42 in the Oseltamivir group).
Current Smoking Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 46 participants 137 participants
Smoker 8 5 4 17
Nonsmoker 36 40 42 118
Missing 1 1 0 2
[1]
Measure Description: A smoker was defined as a subject who had smoked cigarettes in the last 30 days or currently used other tobacco products. Data were available for 135 participants (44 in the Peramivir 200 mg group; 45 in the Peramivir 400 mg group; and 46 in the Oseltamivir group).
Influenza Infection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 46 participants 137 participants
Confirmed Influenza A 26 34 30 90
Confirmed Influenza B 15 6 11 32
Not confirmed 4 6 5 15
[1]
Measure Description: "Confirmed" included all subjects with confirmed influenza defined as a positive polymerase chain reaction (PCR) assay, positive viral culture, or paired serology showing a ≥ 4-fold increase in antibody to influenza A or B.
Transcutaneous Oxygen Saturation at Randomization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 46 participants 137 participants
< 94% 14 14 14 42
>= 94% 31 32 32 95
1.Primary Outcome
Title Time to Clinical Stability (Kaplan-Meier Estimate)
Hide Description Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description:
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Overall Number of Participants Analyzed 41 40 41
Median (95% Confidence Interval)
Unit of Measure: hours
23.7
(16.0 to 38.9)
37.0
(22.0 to 48.7)
28.1
(22.0 to 37.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments [Not Specified]
Method Log Rank
Comments Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.
2.Secondary Outcome
Title Change From Baseline in Scores of Symptoms of Influenza
Hide Description Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (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]) were tabulated by treatment group. Missing data were excluded.
Time Frame Baseline, Days 2, 3, 4, 5, 10, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description:
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Overall Number of Participants Analyzed 41 40 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sore Throat: Baseline 1.3  (1.09) 1.1  (1.17) 1.2  (1.19)
Sore Throat: Change at Day 2 -0.2  (0.95) -0.3  (1.09) -0.3  (0.80)
Sore Throat: Change at Day 3 -0.8  (1.05) -0.7  (1.24) -0.8  (1.04)
Sore Throat: Change at Day 4 -0.9  (1.13) -0.9  (1.24) -1.1  (1.18)
Sore Throat: Change at Day 5 -1.1  (1.07) -0.9  (1.20) -1.1  (1.24)
Sore Throat: Change at Day 10 -1.2  (1.03) -1.1  (1.15) -1.2  (1.18)
Sore Throat: Change at Day 14 -1.2  (1.05) -1.1  (1.16) -1.1  (1.17)
Nasal Congestion: Baseline 1.3  (1.17) 1.5  (1.03) 1.3  (1.08)
Nasal Congestion: Change at Day 2 -0.2  (1.06) -0.5  (0.82) -0.3  (0.82)
Nasal Congestion: Change at Day 3 -0.7  (1.18) -0.9  (0.99) -0.8  (0.96)
Nasal Congestion: Change at Day 4 -0.8  (1.32) -1.1  (1.06) -1.0  (1.16)
Nasal Congestion: Change at Day 5 -0.9  (1.27) -1.2  (1.17) -1.1  (1.10)
Nasal Congestion: Change at Day 10 -1.1  (1.23) -1.2  (1.27) -1.1  (1.17)
Nasal Congestion: Change at Day 14 -1.0  (1.22) -1.2  (1.17) -1.3  (1.08)
Cough: Baseline 2.2  (0.73) 2.0  (0.77) 2.1  (0.76)
Cough: Change at Day 2 -0.4  (0.88) -0.3  (0.74) -0.2  (0.81)
Cough: Change at Day 3 -0.9  (0.91) -0.9  (1.07) -0.9  (0.87)
Cough: Change at Day 4 -1.1  (1.10) -1.1  (1.05) -1.0  (1.07)
Cough: Change at Day 5 -1.2  (0.97) -1.1  (1.23) -1.1  (1.17)
Cough: Change at Day 10 -1.4  (0.97) -1.2  (1.07) -1.3  (1.11)
Cough: Change at Day 14 -1.6  (1.06) -1.4  (1.01) -1.5  (1.09)
Aches and Pains: Baseline 1.8  (1.30) 1.9  (1.13) 1.9  (1.09)
Aches and Pains: Change at Day 2 -0.8  (1.01) -0.8  (0.91) -0.8  (1.08)
Aches and Pains: Change at Day 3 -1.3  (1.14) -1.4  (1.18) -1.4  (1.14)
Aches and Pains: Change at Day 4 -1.5  (1.28) -1.6  (1.21) -1.6  (1.21)
Aches and Pains: Change at Day 5 -1.6  (1.31) -1.6  (1.23) -1.7  (1.31)
Aches and Pains: Change at Day 10 -1.7  (1.38) -1.7  (1.12) -1.9  (1.09)
Aches and Pains: Change at Day 14 -1.7  (1.35) -1.6  (1.11) -1.7  (1.30)
Fatigue: Baseline 2.3  (0.78) 2.0  (0.96) 2.3  (0.82)
Fatigue: Change at Day 2 -0.9  (0.96) -0.5  (1.12) -1.0  (1.11)
Fatigue: Change at Day 3 -1.2  (1.02) -1.0  (1.26) -1.1  (1.17)
Fatigue: Change at Day 4 -1.4  (1.21) -1.2  (1.30) -1.6  (1.11)
Fatigue: Change at Day 5 -1.6  (1.09) -1.3  (1.27) -1.7  (1.09)
Fatigue: Change at Day 10 -1.7  (1.05) -1.4  (1.13) -1.7  (1.09)
Fatigue: Change at Day 14 -1.7  (1.13) -1.6  (1.01) -2.0  (0.97)
Headache: Baseline 1.5  (1.22) 1.3  (1.34) 1.4  (1.30)
Headache: Change at Day 2 -0.5  (1.11) -0.5  (1.12) -0.6  (0.94)
Headache: Change at Day 3 -0.9  (1.16) -1.0  (1.26) -1.0  (1.10)
Headache: Change at Day 4 -1.0  (1.25) -1.1  (1.30) -1.1  (1.30)
Headache: Change at Day 5 -1.2  (1.21) -1.1  (1.28) -1.3  (1.30)
Headache: Change at Day 10 -1.3  (1.24) -1.2  (1.35) -1.4  (1.26)
Headache: Change at Day 14 -1.3  (1.19) -1.2  (1.35) -1.3  (1.34)
Feeling Feverish: Baseline 2.1  (1.04) 1.9  (0.99) 1.8  (1.20)
Feeling Feverish: Change at Day 2 -1.4  (1.02) -1.0  (0.94) -1.0  (1.15)
Feeling Feverish: Change at Day 3 -1.5  (1.01) -1.5  (0.93) -1.6  (1.20)
Feeling Feverish: Change at Day 4 -1.8  (1.15) -1.8  (0.97) -1.6  (1.48)
Feeling Feverish: Change at Day 5 -1.9  (1.02) -1.8  (1.02) -1.8  (1.20)
Feeling Feverish: Change at Day 10 -2.0  (1.07) -1.8  (1.00) -1.8  (1.18)
Feeling Feverish: Change at Day 14 -1.9  (1.21) -1.7  (1.01) -1.8  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
3.Secondary Outcome
Title Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)
Hide Description Changes in each subject’s ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject’s ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description:
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Overall Number of Participants Analyzed 40 39 41
Median (95% Confidence Interval)
Unit of Measure: hours
8.8
(4.0 to 14.5)
9.0 [1] 
(6.8 to NA)
13.7
(10.0 to 20.7)
[1]
The number of observed events was too small to allow estimation of the required parameter.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)
Hide Description The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description:
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Overall Number of Participants Analyzed 41 40 41
Measure Type: Number
Unit of Measure: participants
0 0 0
5.Secondary Outcome
Title Time to Hospital Discharge (Kaplan-Meier Estimate)
Hide Description Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description:
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Overall Number of Participants Analyzed 41 40 41
Median (95% Confidence Interval)
Unit of Measure: hours
4.0
(3.0 to 4.7)
3.8
(2.7 to 4.8)
4.0
(2.9 to 4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.994
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)
Hide Description Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.
Time Frame Baseline, and 12, 24, 36, 48, 72, and 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 122 subjects with confirmed influenza (intent-to-treat infected [ITTI]) population, a total of 112 subjects had positive virus cultures obtained from baseline nasopharyngeal specimens.
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description:
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Overall Number of Participants Analyzed 39 34 39
Mean (Standard Deviation)
Unit of Measure: log10 TCID50/mL
Duration <48 Hours: Baseline 3.6  (1.33) 3.5  (1.01) 3.4  (1.44)
Duration <48 Hours: Change at 12 hours -1.5  (1.33) -1.6  (1.29) -1.5  (1.01)
Duration <48 Hours: Change at 24 hours -2.5  (0.93) -2.2  (0.84) -2.2  (0.99)
Duration <48 Hours: Change at 48 hours -2.4  (0.93) -2.9  (0.77) -2.5  (1.45)
Duration <48 Hours: Change at 96 hours -2.8  (1.28) -3.0  (0.97) -2.8  (1.05)
Duration ≥48 and ≤72 hours: Baseline 2.8  (1.38) 2.6  (1.35) 2.5  (1.27)
Duration ≥48 and ≤72 hours: Change at 12 hours -1.1  (1.03) -1.5  (1.27) -0.7  (1.12)
Duration ≥48 and ≤72 hours: Change at 24 hours -1.4  (0.92) -1.7  (1.22) -1.0  (0.75)
Duration ≥48 and ≤72 hours: Change at 48 hours -1.8  (1.17) -1.9  (1.16) -1.5  (0.85)
Duration ≥48 and ≤72 hours: Change at 96 hours -2.6  (1.29) -2.0  (1.38) -1.7  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Change from Baseline at 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Change from Baseline at 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Change from Baseline at 36 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Change from Baseline at 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Change from Baseline at 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Comments Change from Baseline at 96 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Time Frame Adverse events were collected from the time of study drug administration through the follow-up period ending on Day 14.
Adverse Event Reporting Description For subjects who experienced the same coded event more than once, only one event is presented.
 
Arm/Group Title Peramivir 200 mg Peramivir 400 mg Oseltamivir
Hide Arm/Group Description Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
All-Cause Mortality
Peramivir 200 mg Peramivir 400 mg Oseltamivir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peramivir 200 mg Peramivir 400 mg Oseltamivir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/45 (4.44%)   8/46 (17.39%)   4/46 (8.70%) 
Blood and lymphatic system disorders       
Anaemia  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Hypocoagulable state  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Cardiac disorders       
Supraventricular tachycardia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Gastrointestinal disorders       
Diarrhoea  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Gastrointestinal haemorrhage  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Infections and infestations       
Pneumonia  1  0/45 (0.00%)  3/46 (6.52%)  0/46 (0.00%) 
Respiratory tract infection  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Viral myocarditis  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Nervous system disorders       
Presyncope  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Renal and urinary disorders       
Proteinuria  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Urinary retention  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Chronic obstructive pulmonary disease  1  0/45 (0.00%)  1/46 (2.17%)  1/46 (2.17%) 
Respiratory failure  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Peramivir 200 mg Peramivir 400 mg Oseltamivir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/45 (55.56%)   21/46 (45.65%)   19/46 (41.30%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  1/45 (2.22%)  0/46 (0.00%)  1/46 (2.17%) 
Neutropenia  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Anaemia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Leukopenia  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Cardiac disorders       
Arrhythmia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Atrial Fibrillation  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Bradycardia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Cardiac Failure Congestive  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Cardiomegaly  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Ventricular Tachycardia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Endocrine disorders       
Thyroiditis  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Eye disorders       
Vision Blurred  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  5/45 (11.11%)  7/46 (15.22%)  1/46 (2.17%) 
Nausea  1  2/45 (4.44%)  5/46 (10.87%)  4/46 (8.70%) 
Constipation  1  3/45 (6.67%)  0/46 (0.00%)  1/46 (2.17%) 
Vomiting  1  1/45 (2.22%)  0/46 (0.00%)  1/46 (2.17%) 
Abdominal Discomfort  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Abdominal Pain  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Abdominal Pain Upper  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Dry Mouth  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Dysphagia  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Epigastric Discomfort  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Gastrooesophageal Reflux Disease  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Gingival Pain  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Haemorrhoidal Haemorrhage  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
General disorders       
Oedema  1  0/45 (0.00%)  0/46 (0.00%)  2/46 (4.35%) 
Chest Pain  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Infusion Site Pain  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Infusion Site Pruritus  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Malaise  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Non-cardiac Chest Pain  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Pain  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Pyrexia  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Vessel Puncture Site Haematoma  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Immune system disorders       
Hypersensitivity  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Infections and infestations       
Bacterial Sepsis  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Bronchiectasis  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Candidiasis  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Fungal Skin Infection  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Oral Candidiasis  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Pneumonia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Staphylococcal Sepsis  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Urinary Tract Infection  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Injury, poisoning and procedural complications       
Contusion  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Investigations       
Alanine Aminotransferase Increased  1  1/45 (2.22%)  0/46 (0.00%)  1/46 (2.17%) 
Aspartate Aminotransferase Increased  1  1/45 (2.22%)  0/46 (0.00%)  1/46 (2.17%) 
Blood Creatine Phosphokinase Increased  1  0/45 (0.00%)  2/46 (4.35%)  0/46 (0.00%) 
Blood Alkaline Phosphatase Decreased  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Blood Lactate Dehydrogenase Increased  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Blood Magnesium Decreased  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Blood Pressure Increased  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Brain Natriuretic Peptide Increased  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Electrocardiogram Change  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Electrocardiogram Qt Prolonged  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Hepatic Enzyme Increased  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Lymphocyte Count Decreased  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Weight Decreased  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
White Blood Cell Count Increased  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  3/45 (6.67%)  4/46 (8.70%)  5/46 (10.87%) 
Hyperglycaemia  1  2/45 (4.44%)  2/46 (4.35%)  2/46 (4.35%) 
Anorexia  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Hypoalbuminaemia  1  0/45 (0.00%)  1/46 (2.17%)  1/46 (2.17%) 
Hypocalcaemia  1  0/45 (0.00%)  0/46 (0.00%)  2/46 (4.35%) 
Decreased Appetite  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Hypomagnesaemia  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Hyponatraemia  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Hypoproteinaemia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  1/45 (2.22%)  0/46 (0.00%)  1/46 (2.17%) 
Muscle Spasms  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Musculoskeletal Discomfort  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Nervous system disorders       
Headache  1  1/45 (2.22%)  2/46 (4.35%)  0/46 (0.00%) 
Dizziness  1  0/45 (0.00%)  1/46 (2.17%)  1/46 (2.17%) 
Dizziness Postural  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Paraesthesia  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Somnolence  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Tremor  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Psychiatric disorders       
Insomnia  1  2/45 (4.44%)  2/46 (4.35%)  2/46 (4.35%) 
Anxiety  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Depression  1  2/45 (4.44%)  0/46 (0.00%)  0/46 (0.00%) 
Confusional State  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Delirium  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Mood Altered  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Nightmare  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Restlessness  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Renal and urinary disorders       
Proteinuria  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/45 (2.22%)  1/46 (2.17%)  1/46 (2.17%) 
Dyspnoea  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Atelectasis  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Bronchial Secretion Retention  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Epistaxis  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Haemoptysis  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Hypoxia  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Paranasal Sinus Hypersecretion  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Pharyngeal Erythema  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Pleural Effusion  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Productive Cough  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Sputum Discoloured  1  0/45 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Wheezing  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry Skin  1  0/45 (0.00%)  1/46 (2.17%)  1/46 (2.17%) 
Pruritus  1  0/45 (0.00%)  1/46 (2.17%)  1/46 (2.17%) 
Rash  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Rash Maculo-papular  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Rash Papular  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Urticaria  1  1/45 (2.22%)  0/46 (0.00%)  0/46 (0.00%) 
Vascular disorders       
Hypotension  1  1/45 (2.22%)  1/46 (2.17%)  0/46 (0.00%) 
Hypertension  1  0/45 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William P. Sheridan, MBBS
Organization: BioCryst Pharmaceuticals, Inc.
Phone: 919-859-1302
Layout table for additonal information
Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00453999     History of Changes
Other Study ID Numbers: BCX1812-201
First Submitted: March 27, 2007
First Posted: March 29, 2007
Results First Submitted: January 16, 2015
Results First Posted: February 12, 2015
Last Update Posted: February 12, 2015