Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000282482
Ethics application status
Not yet submitted
Date submitted
24/05/2007
Date registered
28/05/2007
Date last updated
28/05/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
To evaluate the effects on time to clinical stability associated with treatment with peramivir administered intravenously compared to oral oseltamivir in adults hospitalized with acute serious or potentially life-threatening influenza
Scientific title
A Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing the Efficacy and Safety of Peramivir Administered Intravenously Once Daily versus Oseltamivir Administered Orally Twice Daily in Adults with Acute Serious or Potentially Life-Threatening Influenza.
To evaluate the effects on time to clinical stability associated with treatment with peramivir administered intravenously compared to oral oseltamivir in adults hospitalized with acute serious or potentially life-threatening influenza
Universal Trial Number (UTN)
Trial acronym
BCX1812-201
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 1822 0
Life threatening comorbidities suchs as COPD, congestive heart failure and diabetes. 1823 0
Condition category
Condition code
Respiratory 1913 1913 0 0
Other respiratory disorders / diseases
Respiratory 1914 1914 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 1915 1915 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects with signs and symptoms compatible with acute influenza infection will be evaluated for participation. Enrolled subjects will be randomized to receive one of three treatments:
Treatment Group 1: Peramivir (BCX-1812) 200 mg, administered intravenously, once daily (q 24 hrs) for 5 days (5 doses)

Treatment Group 2: Peramivir BCX-1812) 400 mg, administered intravenously, once daily (q 24 hrs) for 5 days (5 doses)

Treatment Group 3: Oseltamivir 75 mg, ( oral suspension) administered per-oral, twice daily for 5 days (10 doses)
Intervention code [1] 1777 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2726 0
Time to clinical stability, defined as normalization of at least four of the five signs described below within the respective normalization criteria shown, for at least 24-hours:
- Sign of Clinical Stability Normalization Criteria.
- Temperature = 37.2° C (= 99° F) Oral.
- Oxygen saturation = 92% *.
- Respiration rate = 24/minute.
- Heart rate = 100/minute.
- Systolic BP = 90 mm Hg.
Timepoint [1] 2726 0
Secondary outcome [1] 4594 0
Change (reduction) in influenza virus titer by TCID50
Timepoint [1] 4594 0
From baseline to end of drug treatment (day 5).
Secondary outcome [2] 4595 0
Change in presence and severity of each of seven symptoms of influenza.
Timepoint [2] 4595 0
Change is assessed twice daily from day 1-5 and once at day 10 & 14.
Secondary outcome [3] 4596 0
Time to resumption of usual daily activities.
Timepoint [3] 4596 0
Assessed twice daily from day 1-5 and once on day 10 & 14.
Secondary outcome [4] 4597 0
Clinical relapse
Timepoint [4] 4597 0
Defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours, after clinical stability had been attained, assessed daily.
Secondary outcome [5] 4598 0
Time to hospital discharge
Timepoint [5] 4598 0
Secondary outcome [6] 4599 0
Chest roentgenogram (if applicable)
Timepoint [6] 4599 0
Change from baseline to day 14.
Secondary outcome [7] 4600 0
Mortality (during the hospitalization during which the subject received study drug treatment)
Timepoint [7] 4600 0

Eligibility
Key inclusion criteria
Able to provide informed consent, or for whom consent may be provided by guardian 3. Presence of fever at time of screening of =38.0 °C (100.4 °F) taken orally, or =38.5 °C (101.2 °F) taken rectally. Note: subject may be enrolled with temperature less than that stated above if there is a history of fever in the past 24-hours and the subject has administered any antipyretic medication(s) in the 6 hours prior to screening4. Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion/symptoms) of any severity (mild, moderate, or severe)5. Presence of at least one constitutional symptom (headache, myalgia, feverishness, malaise, or fatigue) of any severity (mild, moderate, or severe)6. Onset of illness no more than 72 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 degree (°C) 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 7. Presence of one or more of the following factors in a subject who is willing to be hospitalized for inpatient observation and treatment:• Age =60 years• Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy• History of congestive heart failure with or without medically significant recent change in cardiac status, but without signs or symptoms compatible with NYHA Class IV functional status• Presence of diabetes mellitus, clinically stable or unstable• Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value• Systolic blood pressure <90 mmHg• Severity of illness that, in the Investigator’s judgment, justifies hospitalization of the subject for supportive care8. Positive rapid antigen test (RAT) for influenza A and/or influenza B (using an approved test kit) at the screening/enrollment evaluation9. Females of childbearing potential must report one of the following:• Be surgically sterile or clinically post-menopausal• 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 for all perimenopausal women or women of child-bearing potential• 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 for all perimenopausal women or women of child-bearing potential• 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 for all perimenopausal women or women of child-bearing potential
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Immunized against influenza with live attenuated virus vaccine in the previous 3 weeks2. Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in the previous 7 days3. Serum creatinine laboratory result at screening of > 1.6 mg/dL or a result that is > 25% above the upper limit of normal for the laboratory performing the test4. Historical evidence of clinically significant proteinuria or documented 24-hour protein excretion of >1.0 Gm, and/or previous clinical laboratory data indicating an estimated creatinine clearance <50 mL/min during the previous 12 months5. Electrocardiogram (ECG) at screening visit showing evidence of acute ischemia, or presence of a medically significant dysrhythmia6. Presence of cardiac signs or symptoms compatible with NYHA Class IV functional status7. Presence of diagnosed COPD or other chronic lung condition requiring continuous or intermittent oxygen therapy as an outpatient 8. History of organ transplantation during the previous 12 months9. HIV infection with most recent CD4 cell count =350 cells/mL10. History of gastrointestinal bleeding or gastrointestinal surgery during the previous 12 months11. History of diagnosis of any type of cancer (hematologic or solid tumor), that has required chemotherapy or radiation therapy in the previous 12 months, excluding non-melanomatous localized skin cancer12. Requirement for chronic mechanical ventilation, either via oral or nasotracheal intubation or via tracheostomy, or chronic or intermittent requirement for BiPAP (bilevel positive airway pressure) at screening. Note: subjects who are determined to require acute supplemental oxygen therapy at time of screening and/or at hospital admission may be enrolled13. History of alcohol abuse or drug addiction during the previous 12 months14. Participation in a clinical study of an experimental medication or other treatment during the previous 4 weeks15. Previous treatment with peramivir in any dose or formulation16. Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding

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 pharmacist who will be randomising each enrolled patient will be at the investigational site in all centres. Once the Principal Investigator has confirm the inclusion & Exclusion criteria for each patient the Pharmacist will be notified to contact Interactive Voice Response System (IVRS) to centrally randomised each patient via phone computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Initial randomisation of all patients will be based on computer sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study is double masked and double dummy, therefore the Physician that confirms the inclusion/exclusion criteria does not know the patient's treatment. All site staff, such as all Investigators and study coordinators and patients will be blinded to individual treatment. The Pharmacist is the only site member to know of the treatment. The treatment will be passed onto the study coordinator after it has been made up and blinded, therefore the administrator will not know of the treatment type. Once the study have been completed the data will be reviewed but statisticians and analysts who will be unblinded to individual patient treatments.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2059 0
Commercial sector/Industry
Name [1] 2059 0
BioCryst Pharmaceuticals Inc.
Country [1] 2059 0
Primary sponsor type
Commercial sector/Industry
Name
BioCryst Pharmaceuticals Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1866 0
Commercial sector/Industry
Name [1] 1866 0
Quintiles Pty Ltd
Address [1] 1866 0
Country [1] 1866 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3824 0
Princess Alexandra Hospital
Ethics committee address [1] 3824 0
Ethics committee country [1] 3824 0
Australia
Date submitted for ethics approval [1] 3824 0
Approval date [1] 3824 0
Ethics approval number [1] 3824 0
Ethics committee name [2] 3825 0
Sir Charles Gairdner Hospital
Ethics committee address [2] 3825 0
Ethics committee country [2] 3825 0
Australia
Date submitted for ethics approval [2] 3825 0
Approval date [2] 3825 0
Ethics approval number [2] 3825 0
Ethics committee name [3] 3826 0
Repatriation General Hospital
Ethics committee address [3] 3826 0
Ethics committee country [3] 3826 0
Australia
Date submitted for ethics approval [3] 3826 0
Approval date [3] 3826 0
Ethics approval number [3] 3826 0
Ethics committee name [4] 3827 0
Westmead Hospital
Ethics committee address [4] 3827 0
Ethics committee country [4] 3827 0
Australia
Date submitted for ethics approval [4] 3827 0
Approval date [4] 3827 0
Ethics approval number [4] 3827 0
Ethics committee name [5] 3828 0
Royal Melbourne Hospital
Ethics committee address [5] 3828 0
Ethics committee country [5] 3828 0
Australia
Date submitted for ethics approval [5] 3828 0
Approval date [5] 3828 0
Ethics approval number [5] 3828 0
Ethics committee name [6] 3829 0
Mater Adult Hospital
Ethics committee address [6] 3829 0
Ethics committee country [6] 3829 0
Australia
Date submitted for ethics approval [6] 3829 0
Approval date [6] 3829 0
Ethics approval number [6] 3829 0
Ethics committee name [7] 3830 0
Prince of Wales Hospital
Ethics committee address [7] 3830 0
Ethics committee country [7] 3830 0
Australia
Date submitted for ethics approval [7] 3830 0
Approval date [7] 3830 0
Ethics approval number [7] 3830 0

Summary
Brief summary
The primary purpose of this study is to evaluate how effective intra-venously administered Peramivir will be at reducing the symptoms assoicated with complicated Influenza. The success of the medication will be assessed through discussing outcomes with each patient and reviewing the blood samples provided.
The Sponsor's of this study hypothesize that Peramivir intra-venously administered for 5 days will be effective at reducing the duration of influenza symptoms from about 100 hours to 80 hours from illness onset.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27880 0
Address 27880 0
Country 27880 0
Phone 27880 0
Fax 27880 0
Email 27880 0
Contact person for public queries
Name 10966 0
Andrew Booth
Address 10966 0
Level 8/9
67 Albert Ave
Chatswood NSW 2067
Country 10966 0
Australia
Phone 10966 0
02 9016 8212
Fax 10966 0
02 9016 8106
Email 10966 0
andrew.booth@quintiles.com
Contact person for scientific queries
Name 1894 0
Andrew Booth
Address 1894 0
Level 8/9
67 Albert Ave
Chatswood NSW 2067
Country 1894 0
Australia
Phone 1894 0
02 9016 8212
Fax 1894 0
02 9016 8106
Email 1894 0
andrew.booth@quintiles.com

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

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