Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00419263
Recruitment Status : Completed
First Posted : January 8, 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 150 mg
Drug: Peramivir 300 mg
Drug: Placebo
Enrollment 344
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Period Title: Overall Study
Started 115 114 115
Completed 112 112 112
Not Completed 3 2 3
Reason Not Completed
Lost to Follow-up             2             1             1
Randomized in Error, Not Treated             1             1             0
Adverse Event             0             0             1
Withdrawal by Subject             0             0             1
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg Total
Hide Arm/Group Description Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). Total of all reporting groups
Overall Number of Baseline Participants 114 113 115 342
Hide Baseline Analysis Population Description
The safety population included all subjects who received any dose of study drug. Subjects were analyzed according to the treatment received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 113 participants 115 participants 342 participants
33.9  (12.05) 36.2  (15.59) 36.2  (13.25) 35.4  (13.71)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
18 - 27 years old 41 37 34 112
28 - 37 years old 37 31 35 103
38 - 47 years old 19 21 25 65
48 - 57 years old 9 10 12 31
≥ 58 years old 8 13 9 30
Missing 0 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
Female
54
  47.4%
67
  59.3%
62
  53.9%
183
  53.5%
Male
60
  52.6%
46
  40.7%
53
  46.1%
159
  46.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
Hispanic or Latino
6
   5.3%
9
   8.0%
4
   3.5%
19
   5.6%
Not Hispanic or Latino
108
  94.7%
104
  92.0%
111
  96.5%
323
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
   6.1%
4
   3.5%
7
   6.1%
18
   5.3%
Native Hawaiian or Other Pacific Islander
6
   5.3%
8
   7.1%
4
   3.5%
18
   5.3%
Black or African American
21
  18.4%
18
  15.9%
17
  14.8%
56
  16.4%
White
77
  67.5%
78
  69.0%
81
  70.4%
236
  69.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.6%
5
   4.4%
6
   5.2%
14
   4.1%
Body Mass Index at Screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 114 participants 113 participants 115 participants 342 participants
26.5  (5.69) 27.5  (6.23) 27.8  (6.35) 27.2  (6.11)
[1]
Measure Description: 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.
Current Smoking Behavior at Randomization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
Smoker 26 22 25 73
Nonsmoker 88 91 90 269
Estimated Time of Onset of Symptoms at Screening  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
0 - 12 hours ago 1 4 4 9
> 12 - 24 hours ago 37 32 25 94
> 24 - 36 hours ago 45 43 46 134
> 36 - 48 hours ago 31 34 40 105
Initial Composite Symptom Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 114 participants 113 participants 115 participants 342 participants
14.3  (3.70) 14.3  (3.22) 14.1  (3.92) 14.2  (3.62)
[1]
Measure Description: 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.
Influenza Infection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 115 participants 342 participants
Negative 5 9 9 23
Positive 109 104 105 318
Missing 0 0 1 1
[1]
Measure Description: Infection as measured by polymerase chain reaction (PCR) or serology.
Body Surface Area   [1] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 114 participants 113 participants 115 participants 342 participants
1.9  (0.26) 1.9  (0.25) 1.9  (0.28) 1.9  (0.26)
[1]
Measure Description: 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.
1.Primary Outcome
Title Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Hide Description 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.
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 108 104 105
Median (95% Confidence Interval)
Unit of Measure: Hours
136.2
(114.3 to 165.8)
114.1
(95.2 to 145.5)
117.4
(78.0 to 135.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments [Not Specified]
Method Regression, Cox
Comments P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.
2.Secondary Outcome
Title Time to Resolution of Fever
Hide Description 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.
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 108 104 104
Median (95% Confidence Interval)
Unit of Measure: Hours
58.1
(43.0 to 67.7)
43.6
(40.9 to 49.1)
42.9
(40.2 to 46.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Time to Resumption of Ability to Perform Usual Activities
Hide Description 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.
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 108 104 103
Median (95% Confidence Interval)
Unit of Measure: Days
10.1
(9.1 to 11.4)
9.2
(8.1 to 11.4)
8.3
(7.3 to 10.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.537
Comments P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Day 2 in Influenza Virus Titer
Hide Description 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).
Time Frame Baseline and approximately 24 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 103 97 100
Median (Full Range)
Unit of Measure: log10(TCID50/mL)
-1.50
(-5.25 to 2.50)
-2.00
(-5.25 to 2.25)
-2.25
(-5.25 to 1.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Day 3 in Influenza Virus Titer
Hide Description 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).
Time Frame Baseline and approximately 48 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 104 98 98
Median (Full Range)
Unit of Measure: log10(TCID50/mL)
-2.75
(-5.00 to 1.00)
-3.00
(-5.25 to 1.00)
-3.25
(-6.00 to 1.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Day 5 in Influenza Virus Titer
Hide Description 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).
Time Frame Baseline and approximately 96 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 103 98 100
Median (Full Range)
Unit of Measure: log10(TCID50/mL)
-3.75
(-5.50 to -0.25)
-3.38
(-6.50 to 0.00)
-3.63
(-6.50 to 0.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Day 9 in Influenza Virus Titer
Hide Description 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).
Time Frame Baseline and approximately 192 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg
Hide Arm/Group Description:
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Overall Number of Participants Analyzed 103 97 100
Median (Full Range)
Unit of Measure: log10(TCID50/mL)
-3.75
(-5.75 to -0.25)
-3.75
(-6.50 to 2.00)
-3.75
(-6.75 to -0.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Peramivir 150 mg, Peramivir 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.327
Comments The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Peramivir 150 mg Peramivir 300 mg Total
Hide Arm/Group Description Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). Total number of subjects who received at least 1 dose of study drug
All-Cause Mortality
Placebo Peramivir 150 mg Peramivir 300 mg Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Peramivir 150 mg Peramivir 300 mg Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/114 (0.88%)      0/113 (0.00%)      1/115 (0.87%)      2/342 (0.58%)    
Infections and infestations         
Meningitis  1  0/114 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 1/342 (0.29%)  1
Pyelonephritis  1  1/114 (0.88%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 1/342 (0.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Peramivir 150 mg Peramivir 300 mg Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/114 (27.19%)      27/113 (23.89%)      25/115 (21.74%)      83/342 (24.27%)    
Gastrointestinal disorders         
Diarrhoea  1  5/114 (4.39%)  5/113 (4.42%)  6/115 (5.22%)  16/342 (4.68%) 
Nausea  1  7/114 (6.14%)  7/113 (6.19%)  9/115 (7.83%)  23/342 (6.73%) 
Vomiting  1  5/114 (4.39%)  4/113 (3.54%)  2/115 (1.74%)  11/342 (3.22%) 
Investigations         
Aspartate aminotransferase increased  1  2/114 (1.75%)  2/113 (1.77%)  3/115 (2.61%)  7/342 (2.05%) 
Nervous system disorders         
Dizziness  1  3/114 (2.63%)  3/113 (2.65%)  5/115 (4.35%)  11/342 (3.22%) 
Syncope vasovagal  1  4/114 (3.51%)  2/113 (1.77%)  0/115 (0.00%)  6/342 (1.75%) 
Psychiatric disorders         
Insomnia  1  2/114 (1.75%)  5/113 (4.42%)  0/115 (0.00%)  7/342 (2.05%) 
Renal and urinary disorders         
Proteinuria  1  7/114 (6.14%)  10/113 (8.85%)  5/115 (4.35%)  22/342 (6.43%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  4/114 (3.51%)  1/113 (0.88%)  1/115 (0.87%)  6/342 (1.75%) 
Epistaxis  1  0/114 (0.00%)  1/113 (0.88%)  3/115 (2.61%)  4/342 (1.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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: NCT00419263    
Other Study ID Numbers: BCX1812-211
First Submitted: January 4, 2007
First Posted: January 8, 2007
Results First Submitted: January 16, 2015
Results First Posted: February 12, 2015
Last Update Posted: February 12, 2015