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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Peramivir 150 mg	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Peramivir 300 mg	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).

Participant Flow:   Overall Study

	Placebo	Peramivir 150 mg	Peramivir 300 mg
STARTED	115	114	115
COMPLETED	112	112	112
NOT COMPLETED	3	2	3
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

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 safety population included all subjects who received any dose of study drug. Subjects were analyzed according to the treatment received.

Reporting Groups

	Description
Placebo	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Peramivir 150 mg	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Peramivir 300 mg	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Total	Total of all reporting groups

Baseline Measures

	Placebo	Peramivir 150 mg	Peramivir 300 mg	Total
Overall Participants Analyzed  [Units: Participants]	114	113	115	342
Age  [Units: Years] Mean (Standard Deviation)	33.9  (12.05)	36.2  (15.59)	36.2  (13.25)	35.4  (13.71)
Age, Customized  [Units: 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
Gender  [Units: Participants]
Female	54	67	62	183
Male	60	46	53	159
Ethnicity (NIH/OMB)  [Units: Participants]
Hispanic or Latino	6	9	4	19
Not Hispanic or Latino	108	104	111	323
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB)  [Units: Participants]
American Indian or Alaska Native	0	0	0	0
Asian	7	4	7	18
Native Hawaiian or Other Pacific Islander	6	8	4	18
Black or African American	21	18	17	56
White	77	78	81	236
More than one race	0	0	0	0
Unknown or Not Reported	3	5	6	14
Body Mass Index at Screening [1]  [Units: Kg/m^2] Mean (Standard Deviation)	26.5  (5.69)	27.5  (6.23)	27.8  (6.35)	27.2  (6.11)
[1] 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  [Units: Participants]
Smoker	26	22	25	73
Nonsmoker	88	91	90	269
Estimated Time of Onset of Symptoms at Screening  [Units: 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]  [Units: Units on a scale] Mean (Standard Deviation)	14.3  (3.70)	14.3  (3.22)	14.1  (3.92)	14.2  (3.62)
[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. 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]  [Units: Participants]
Negative	5	9	9	23
Positive	109	104	105	318
Missing	0	0	1	1
[1] Infection as measured by polymerase chain reaction (PCR) or serology.
Body Surface Area [1]  [Units: M^2] Mean (Standard Deviation)	1.9  (0.26)	1.9  (0.25)	1.9  (0.28)	1.9  (0.26)
[1] 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:

Time to Alleviation of Symptoms (Kaplan-Meier Estimate)   [ Time Frame: Up to 14 days ]

2.  Secondary:

Time to Resolution of Fever   [ Time Frame: Up to 14 days ]

3.  Secondary:

Time to Resumption of Ability to Perform Usual Activities   [ Time Frame: Up to 14 days ]

4.  Secondary:

Change From Baseline to Day 2 in Influenza Virus Titer   [ Time Frame: Baseline and approximately 24 hours after treatment ]

5.  Secondary:

Change From Baseline to Day 3 in Influenza Virus Titer   [ Time Frame: Baseline and approximately 48 hours after treatment ]

6.  Secondary:

Change From Baseline to Day 5 in Influenza Virus Titer   [ Time Frame: Baseline and approximately 96 hours after treatment ]

7.  Secondary:

Change From Baseline to Day 9 in Influenza Virus Titer   [ Time Frame: Baseline and approximately 192 hours after treatment ]

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
Placebo	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Peramivir 150 mg	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Peramivir 300 mg	Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Total	Total number of subjects who received at least 1 dose of study drug

Other Adverse Events

	Placebo	Peramivir 150 mg	Peramivir 300 mg	Total
Total, Other (not including serious) Adverse Events
# participants affected / at risk	31/114 (27.19%)	27/113 (23.89%)	25/115 (21.74%)	83/342 (24.27%)
Gastrointestinal disorders
Diarrhoea † 1
# participants affected / at risk	5/114 (4.39%)	5/113 (4.42%)	6/115 (5.22%)	16/342 (4.68%)
Nausea † 1
# participants affected / at risk	7/114 (6.14%)	7/113 (6.19%)	9/115 (7.83%)	23/342 (6.73%)
Vomiting † 1
# participants affected / at risk	5/114 (4.39%)	4/113 (3.54%)	2/115 (1.74%)	11/342 (3.22%)
Investigations
Aspartate aminotransferase increased † 1
# participants affected / at risk	2/114 (1.75%)	2/113 (1.77%)	3/115 (2.61%)	7/342 (2.05%)
Nervous system disorders
Dizziness † 1
# participants affected / at risk	3/114 (2.63%)	3/113 (2.65%)	5/115 (4.35%)	11/342 (3.22%)
Syncope vasovagal † 1
# participants affected / at risk	4/114 (3.51%)	2/113 (1.77%)	0/115 (0.00%)	6/342 (1.75%)
Psychiatric disorders
Insomnia † 1
# participants affected / at risk	2/114 (1.75%)	5/113 (4.42%)	0/115 (0.00%)	7/342 (2.05%)
Renal and urinary disorders
Proteinuria † 1
# participants affected / at risk	7/114 (6.14%)	10/113 (8.85%)	5/115 (4.35%)	22/342 (6.43%)
Respiratory, thoracic and mediastinal disorders
Asthma † 1
# participants affected / at risk	4/114 (3.51%)	1/113 (0.88%)	1/115 (0.87%)	6/342 (1.75%)
Epistaxis † 1
# participants affected / at risk	0/114 (0.00%)	1/113 (0.88%)	3/115 (2.61%)	4/342 (1.17%)

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
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