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

• 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: BioCryst Pharmaceuticals
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Peramivir 150 mg	Peramivir 300 mg
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

Baseline Characteristics

Arm/Group Title		Placebo	Peramivir 150 mg	Peramivir 300 mg	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo		Peramivir 150 mg		Peramivir 300 mg		Total
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	--/--		--/--		--/--		--/--
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
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)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: William P. Sheridan, MBBS
• Organization: BioCryst Pharmaceuticals, Inc.
• Phone: (919) 859-1302

• 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