Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza

Keywords

influenzaflu

Outcome Measures

Primary Outcomes (1)

Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
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.
Up to 14 days

Secondary Outcomes (6)

Time to Resolution of Fever
Up to 14 days
Time to Resumption of Ability to Perform Usual Activities
Up to 14 days
Change From Baseline to Day 2 in Influenza Virus Titer
Baseline and approximately 24 hours after treatment
Change From Baseline to Day 3 in Influenza Virus Titer
Baseline and approximately 48 hours after treatment
Change From Baseline to Day 5 in Influenza Virus Titer
Baseline and approximately 96 hours after treatment
+1 more secondary outcomes

Study Arms (3)

Peramivir 150 mg

EXPERIMENTAL

Drug: Peramivir 150 mg

Peramivir 300 mg

EXPERIMENTAL

Drug: Peramivir 300 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Peramivir 150 mgDrug

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

Also known as: BCX1812

Peramivir 150 mg

Peramivir 300 mgDrug

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years
Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. However, this requirement is waived if the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening.

Sponsors & Collaborators

BioCryst Pharmaceuticals
Industrylead

Study Sites (69)

Radiant Research

Birmingham, Alabama, 35209, United States

Clopton Clinic

Jonesboro, Arkansas, 72401, United States

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Orange County Clinical Trials

Anaheim, California, 92801, United States

Medical Center

Carmichael, California, 95608, United States

Pacific Sleep Medicines Service

El Centro, California, 92243, United States

Advanced Clinical Research Institute

Orange, California, 92869, United States

MeSH Terms

Conditions

Influenza, Human

Interventions

peramivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title: William P. Sheridan, MBBS
Organization: BioCryst Pharmaceuticals, Inc.

Study Officials

Stanley Block, MD
Kentucky Pediatric/Adult Research
PRINCIPAL INVESTIGATOR
James Borders, MD
Central Kentucky Research Assoc, Inc
PRINCIPAL INVESTIGATOR
Robert Broker, MD
Hillcrest Family Practice
PRINCIPAL INVESTIGATOR
Paul Browstone, MD
Alpine Clinical Research Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

344 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

January 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Peramivir 150 mg

Peramivir 300 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (69)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Peramivir 150 mg

Peramivir 300 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (69)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations