A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

BioCryst Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00705406

First received: June 24, 2008

Last updated: February 12, 2015

Last verified: February 2015

History of Changes

Results First Received: January 16, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Investigator); Primary Purpose: Treatment
Condition:	Acute, Uncomplicated Human Influenza
Interventions:	Drug: Peramivir Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Participant Flow: Overall Study

	Placebo	Peramivir 600 mg
STARTED	203	202
COMPLETED	199	197
NOT COMPLETED	4	5
Lost to Follow-up	3	3
Did not receive study drug	1	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT)

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
Total	Total of all reporting groups

Baseline Measures

Placebo

Peramivir 600 mg

Total

Overall Participants Analyzed
[Units: Participants]

203

202

405

Age
[Units: Years]
Mean (Standard Deviation)

35 (11.3)

35 (12.1)

35 (11.7)

Gender
[Units: Participants]

Female

104

102

206

Male

100

199

Race/Ethnicity, Customized ^[1]
[Units: Participants]

White or Caucasian

101

106

207

Black or African American

129

Asian

American Indian or Alaska Native

Other

^[1]	Participants may have been counted in more than 1 category; therefore, numbers may add up to more than the total number of participants.

Body Mass Index (BMI)
[Units: Kg/m^2]
Mean (Standard Deviation)

27.5 (6.73)

27.2 (6.12)

27.4 (6.43)

Estimated Time of Onset of Symptoms at Screening
[Units: Participants]

0-12 h Ago

12-24 h Ago

172

24-36 h Ago

104

203

Data Missing

Initial Composite Symptom Score ^[1]
[Units: Units on a scale]
Mean (Standard Deviation)

14 (4.3)

14 (3.9)

14 (4.1)

^[1]

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.

Rapid Antigen Test (RAT) Results ^[1]
[Units: Participants]

Positive

202

200

402

No data reported

^[1]	Positive influenza infection confirmed by PCR or virus culture.

Confirmed Influenza Infection Result
[Units: Participants]

Positive by PCR Only

Positive by Viral Culture Only

Positive by PCR and Viral Culture

147

122

269

Negative by PCR and Viral Culture

No Result/Sample

Current Smoking Behavior
[Units: Participants]

Smoker

Nonsmoker

166

165

331

Outcome Measures

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1. Primary:

Time to Alleviation of Symptoms (Kaplan-Meier Estimate) [ Time Frame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 ]

Measure Type	Primary
Measure Title	Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Measure Description	The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Time Frame	Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	147	132
Time to Alleviation of Symptoms (Kaplan-Meier Estimate) [Units: Hours] Median (95% Confidence Interval)	106.9 (90.4 to 127.4)	91.1 (77.7 to 109.7)

Statistical Analysis 1 for Time to Alleviation of Symptoms (Kaplan-Meier Estimate)

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Wilcoxon-Gehan test statistic
P Value ^[4]	0.222
Hazard Ratio (HR) ^[5]	0.927
95% Confidence Interval	0.723 to 1.188

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.

2. Secondary:

Change in Influenza Virus Shedding [ Time Frame: Baseline and Days 3, 4, 9 ]

Measure Type	Secondary
Measure Title	Change in Influenza Virus Shedding
Measure Description	Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).
Time Frame	Baseline and Days 3, 4, 9

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	120	97
Change in Influenza Virus Shedding [Units: log10(TCID50/mL)] Median (95% Confidence Interval)
Change at Day 3	-2.00 (-2.25 to -1.50)	-2.00 (-2.25 to -1.50)
Change at Day 4	-2.25 (-2.75 to -2.00)	-2.25 (-2.75 to -2.00)
Change at Day 9	-2.75 (-3.00 to -2.25)	-2.50 (-2.75 to -2.00)

Statistical Analysis 1 for Change in Influenza Virus Shedding

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	van Elteren test
P Value ^[4]	>0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Other Pre-specified:

Subject’s Severity of Illness (Score*Hours) [ Time Frame: Information collected predose on Day 1 and then once daily through Day 14 ]

Measure Type	Other Pre-specified
Measure Title	Subject’s Severity of Illness (Score*Hours)
Measure Description	A subject’s severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized. The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21.
Time Frame	Information collected predose on Day 1 and then once daily through Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	147	132
Subject’s Severity of Illness (ScoreHours) [Units: Scorehours] Median (Full Range)	777.0 (18.0 to 3542.9)	713.9 (23.5 to 4565.5)

Statistical Analysis 1 for Subject’s Severity of Illness (Score*Hours)

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	van Elteren test
P Value ^[4]	0.421

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

4. Other Pre-specified:

Time to Resolution of Fever [ Time Frame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 ]

Measure Type	Other Pre-specified
Measure Title	Time to Resolution of Fever
Measure Description	Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.
Time Frame	Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	147	132
Time to Resolution of Fever [Units: Hours] Median (95% Confidence Interval)	44.7 (41.5 to 52.2)	44.3 (40.1 to 55.5)

Statistical Analysis 1 for Time to Resolution of Fever

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Wilcoxon-Gehan test statistic
P Value ^[4]	0.885

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

5. Other Pre-specified:

Incidence of Influenza-related Complications [ Time Frame: 14 days ]

Measure Type	Other Pre-specified
Measure Title	Incidence of Influenza-related Complications
Measure Description	Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.
Time Frame	14 days

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	149	133
Incidence of Influenza-related Complications [Units: Participants]
Any Influenza-Related Complication	25	29
Otitis	2	4
Sinusitis	17	13
Bronchitis	10	15
Pneumonia	0	3

Statistical Analysis 1 for Incidence of Influenza-related Complications

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Cochran-Mantel-Haenszel
P Value ^[4]	0.306

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

6. Other Pre-specified:

Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50) [ Time Frame: Baseline ]

Measure Type	Other Pre-specified
Measure Title	Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)
Measure Description	Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.
Time Frame	Baseline

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	114	89
Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50) [Units: nM] Mean (Standard Error)
A: H1N1-Baseline Peramivir Susceptibility	67.46 (54.625)	72.27 (88.306)
A: H1N1-Baseline Oseltamivir Susceptibility	983.41 (1129.29)	1007.29 (1425.095)
A: H1N1-Baseline Zanamivir Susceptibility	1.27 (1.131)	1.48 (1.686)

No statistical analysis provided for Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)

7. Other Pre-specified:

Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50) [ Time Frame: Baseline and up to 14 days ]

Measure Type	Other Pre-specified
Measure Title	Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)
Measure Description	Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.
Time Frame	Baseline and up to 14 days

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	39	37
Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50) [Units: Fold Change from Baseline] Mean (Standard Error)
A: H1N1- Fold Change in Peramivir Susceptibility	1.03 (0.660)	1.10 (0.677)
A: H1N1- Fold Change in Oseltamivir Susceptibility	1.20 (1.055)	1.28 (1.441)
A: H1N1- Fold Change in Zanamivir Susceptibility	3.68 (11.882)	2.67 (9.797)

No statistical analysis provided for Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)

8. Other Pre-specified:

Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50) [ Time Frame: Baseline and up to 14 days ]

Measure Type	Other Pre-specified
Measure Title	Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)
Measure Description	Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Time Frame	Baseline and up to 14 days

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir.

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	23	24
Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50) [Units: nM] Mean (Standard Error)
B: Baseline Peramivir Susceptibility	6.47 (2.442)	6.03 (3.633)
B: Baseline Oseltamivir Susceptibility	40.98 (24.202)	28.72 (17.838)
B: Baseline Zanamivir Susceptibility	5.78 (2.682)	4.65 (2.282)

No statistical analysis provided for Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)

9. Other Pre-specified:

Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50) [ Time Frame: Baseline and up to 14 days ]

Measure Type	Other Pre-specified
Measure Title	Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)
Measure Description	Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Time Frame	Baseline and up to 14 days

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).

Reporting Groups

	Description
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Measured Values

	Placebo	Peramivir 600 mg
Participants Analyzed [Units: Participants]	8	12
Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50) [Units: Fold Change from Baseline] Mean (Standard Error)
B: Fold Change in Peramivir Susceptibility	1.27 (1.319)	0.92 (0.442)
B: Fold Change in Oseltamivir Susceptibility	1.24 (0.819)	0.95 (0.374)
B: Fold Change in Zanamivir Susceptibility	1.10 (0.737)	0.95 (0.497)

No statistical analysis provided for Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The majority of the subjects enrolled in this study with a laboratory confirmed influenza infection were infected with an influenza A/H1N1 virus containing an H275Y mutation associated with reduced susecptibility to peramivir and oseltamivir.

More Information

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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:	NCT00705406 History of Changes
Other Study ID Numbers:	BCX1812-212 HHS 0100200700032C ( Other Grant/Funding Number: HHS-BARDA )
Study First Received:	June 24, 2008
Results First Received:	January 16, 2015
Last Updated:	February 12, 2015

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