Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00705406




Registration number
NCT00705406
Ethics application status
Date submitted
24/06/2008
Date registered
26/06/2008
Date last updated
16/02/2015

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
HHS 0100200700032C
Secondary ID [2] 0 0
BCX1812-212
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute, Uncomplicated Human Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Peramivir
Treatment: Drugs - Placebo

Experimental: Peramivir 600 mg - 600 mg peramivir administered as bilateral 2-mL intramuscular injection.

Placebo comparator: Placebo - Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.


Treatment: Drugs: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection

Treatment: Drugs: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Timepoint [1] 0 0
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Secondary outcome [1] 0 0
Change in Influenza Virus Shedding
Timepoint [1] 0 0
Baseline and Days 3, 4, 9

Eligibility
Key inclusion criteria
* Male and non-pregnant female subjects age =18 years.
* A positive Influenza A or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one hour.
* 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. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
* Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
* Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity.
* Onset of symptoms no more than 36 hours before presentation for screening.
* Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breast-feeding.
* Presence of clinically significant signs of acute respiratory distress
* History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma.
* History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
* Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.
* History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min).
* Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.
* Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
* Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
* Currently receiving treatment for viral hepatitis B or viral hepatitis C.
* Presence of known HIV infection with a CD4 count <350 cell/mm3.
* Current therapy with oral warfarin or other systemic anticoagulant.
* Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
* Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
* Immunized against influenza with inactivated virus vaccine within the previous 14 days.
* Receipt of any intramuscular injection with the previous 7 days.
* History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
* Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.
* Participation in a study of any investigational drug or device within the last 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
405
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pacific Medical Centre Blacktown - Blacktown
Recruitment hospital [2] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [3] 0 0
Symbion Pathology - Hurtsville
Recruitment hospital [4] 0 0
Peninsula Medical Centre - Umina
Recruitment hospital [5] 0 0
Rivercity Private Hospital Specialist - Auchenflower
Recruitment hospital [6] 0 0
Caboolture Clinical Research Centre - Caboolture
Recruitment hospital [7] 0 0
Peninsula Specialist Centre - Kpparing
Recruitment hospital [8] 0 0
Health Services -University of Melbourne - Carlton
Recruitment hospital [9] 0 0
Athelstone Medical Clinic - Adelaide
Recruitment hospital [10] 0 0
Trialworks Clinical Research Services - Brisbane
Recruitment hospital [11] 0 0
Dr Doongs Surgery - Burwood
Recruitment hospital [12] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [13] 0 0
Doctors of Ivanhoe, - Melbourne
Recruitment hospital [14] 0 0
Lung Institute of Western Australia, - Nedlands
Recruitment hospital [15] 0 0
Pitt Street Merrylands Medical Centre - Sydney
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2220 - Hurtsville
Recruitment postcode(s) [4] 0 0
2257 - Umina
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4510 - Caboolture
Recruitment postcode(s) [7] 0 0
4021 - Kpparing
Recruitment postcode(s) [8] 0 0
3053 - Carlton
Recruitment postcode(s) [9] 0 0
5076 - Adelaide
Recruitment postcode(s) [10] 0 0
- Brisbane
Recruitment postcode(s) [11] 0 0
- Burwood
Recruitment postcode(s) [12] 0 0
- Darlinghurst
Recruitment postcode(s) [13] 0 0
- Melbourne
Recruitment postcode(s) [14] 0 0
- Nedlands
Recruitment postcode(s) [15] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
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Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
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United States of America
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Massachusetts
Country [18] 0 0
United States of America
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Michigan
Country [19] 0 0
United States of America
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Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
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United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
New Zealand
State/province [37] 0 0
Auckland
Country [38] 0 0
New Zealand
State/province [38] 0 0
Christchurch
Country [39] 0 0
New Zealand
State/province [39] 0 0
Dunedin
Country [40] 0 0
New Zealand
State/province [40] 0 0
Rotorua
Country [41] 0 0
South Africa
State/province [41] 0 0
Capetown
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South Africa
State/province [42] 0 0
Durban
Country [43] 0 0
South Africa
State/province [43] 0 0
Free State
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South Africa
State/province [44] 0 0
Gauteg
Country [45] 0 0
South Africa
State/province [45] 0 0
Gauteng
Country [46] 0 0
South Africa
State/province [46] 0 0
Krugersdorp
Country [47] 0 0
South Africa
State/province [47] 0 0
Kwa Zulu Natal
Country [48] 0 0
South Africa
State/province [48] 0 0
KZ-Natal
Country [49] 0 0
South Africa
State/province [49] 0 0
Pretoria
Country [50] 0 0
South Africa
State/province [50] 0 0
W. Cape
Country [51] 0 0
South Africa
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Amanzimtoti
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South Africa
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Benoni
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South Africa
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Bloemfontein
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South Africa
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Brits
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South Africa
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Cape town
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Port Elizabeth
Country [59] 0 0
South Africa
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Roodepoort
Country [60] 0 0
South Africa
State/province [60] 0 0
Scottburgh
Country [61] 0 0
South Africa
State/province [61] 0 0
Soweto
Country [62] 0 0
South Africa
State/province [62] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioCryst Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00705406