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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

BioCryst Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00419263

First received: January 4, 2007

Last updated: January 28, 2015

Last verified: January 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, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Influenza
Interventions:	Drug: Peramivir 150 mg Drug: Peramivir 300 mg 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
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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

Baseline Characteristics

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Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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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
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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:	NCT00419263 History of Changes
Other Study ID Numbers:	BCX1812-211
Study First Received:	January 4, 2007
Results First Received:	January 16, 2015
Last Updated:	January 28, 2015

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