Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000284460
Ethics application status
Approved
Date submitted
24/05/2007
Date registered
28/05/2007
Date last updated
28/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo in adult subjects with uncomplicated acute influenza.
Scientific title
A Phase II, Multicenter, Randomized, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza
Universal Trial Number (UTN)
Trial acronym
BCX1812-211
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated influenza. 1825 0
Condition category
Condition code
Respiratory 1917 1917 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multinational, randomized, double-mask study comparing the efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. Subjects will be stratified according to their current smoking behavior and centrally randomized to receive one of three treatments:
Treatment Group 1: Peramivir 150mg
Treatment Group 2: Peramivir 300mg

All treatment arms are a single once of intra-muscular injection.
Intervention code [1] 1781 0
Treatment: Drugs
Comparator / control treatment
Treatment Group 3: Placebo
Placebo will also be administred IM and is identical in colour, viscosity and pH.
Control group
Placebo

Outcomes
Primary outcome [1] 2728 0
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo in adult subjects with uncomplicated acute influenza.
Timepoint [1] 2728 0
Efficacy will be evaluated on day 1, 2, 3, 5, 9, 14 and be determined by the improvements to individuals influenza symptoms.
Secondary outcome [1] 4604 0
To evaluate the safety and tolerability of peramivir administered intramuscularly compared to placebo in adult subjects with uncomplicated acute influenza.
Timepoint [1] 4604 0
Safety and tolerability will be examined at baseline, days 1, 2, 3, 5, 9, & 14 by the Prinicapl Investiagor and daily by the patient using a safety diary.

Eligibility
Key inclusion criteria
2. 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.3. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)4. Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)5. Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.6. Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.7. Females of childbearing potential must report one of the following:• Be surgically sterile• Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study drug administration• Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study drug administration• Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are breast-feeding2. History of diagnosed chronic obstructive pulmonary disease or diagnosis of severe persistent asthma3. History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months5. Immunocompromised status due to illness or previous organ transplant6. Current use of systemic immunosuppressive medications (except inhaled corticosteroids)7. Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days8. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days9. Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics10. Clinically significant signs of acute respiratory distress11. Clinically significant signs of acute cardiac disease12. Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia 13. Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es)14. History of hepatitis B, hepatitis C, or human immunodeficiency virus infection15. History of alcohol abuse or drug addiction within 1 year prior to admission in the study16. Participation in a study of any investigational drug within the last 30 days 17. Positive urine pregnancy test.

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)
The allocation to intervention process will be through a central phone randomisation computer, IVRS.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised sequence will be through computer sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All drug regardless of treatment arm, is provided in vials ready to draw in inject. Each vial is identified only by it's vial number. Once the Investigator enrols the patient, he/she will call the Interactive Voice Response System (IVRS), which will allocate a computer 1:1:1 assignment and a kit number. All vials are identical. The patient, Investigator and all site staff will be blinded to the patient's treatement. Statisical assessors and the sponsor will be unblinded to patient randomisation.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2062 0
Commercial sector/Industry
Name [1] 2062 0
BioCryst Pharmaceuticals Inc.
Country [1] 2062 0
Primary sponsor type
Commercial sector/Industry
Name
BioCryst Pharmaceuticals Inc
Address
Country
United States of America
Secondary sponsor category [1] 1868 0
Commercial sector/Industry
Name [1] 1868 0
Quintiles Pty Ltd
Address [1] 1868 0
Country [1] 1868 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3832 0
Dr Doongs Surgery
Ethics committee address [1] 3832 0
Ethics committee country [1] 3832 0
Australia
Date submitted for ethics approval [1] 3832 0
Approval date [1] 3832 0
22/05/2007
Ethics approval number [1] 3832 0
25/07b

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

Contacts
Principal investigator
Name 27884 0
Address 27884 0
Country 27884 0
Phone 27884 0
Fax 27884 0
Email 27884 0
Contact person for public queries
Name 10970 0
Silvia Gurrieri
Address 10970 0
Quintiles Pty Ltd.
Levels 8/9
67 Albert Ave
Chatswood NSW 2067
Country 10970 0
Australia
Phone 10970 0
02 9016 8100
Fax 10970 0
02 9016 8106
Email 10970 0
[email protected]
Contact person for scientific queries
Name 1898 0
Silvia Gurrieri
Address 1898 0
Quintiles Pty Ltd.
Levels 8/9
67 Albert Ave
Chatswood NSW 2067
Country 1898 0
Australia
Phone 1898 0
02 9016 8100
Fax 1898 0
02 9016 8106
Email 1898 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.