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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00957996
Registration number
NCT00957996
Ethics application status
Date submitted
12/08/2009
Date registered
13/08/2009
Date last updated
12/02/2015
Titles & IDs
Public title
Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
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Scientific title
A Phase 3, Open-Label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza Infection
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Secondary ID [1]
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HHS 0100200700032C
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Secondary ID [2]
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BCX1812-303
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Seasonal Influenza
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Cough
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Sore Throat
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Nasal Congestion
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Myalgia
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Headache
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Fatigue
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Peramivir
Treatment: Drugs - Peramivir
Experimental: Peramivir 300 mg - Peramivir 300 mg twice daily
Experimental: Peramivir 600 mg - Peramivir 600 mg once daily
Treatment: Drugs: Peramivir
300 mg twice daily
Treatment: Drugs: Peramivir
600 mg once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Influenza Virus Titer (48 Hours)
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Assessment method [1]
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The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
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Timepoint [1]
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Baseline and 48 hours
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Secondary outcome [1]
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Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
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Assessment method [1]
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The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
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Timepoint [1]
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Baseline, 48, 108, 216 hours
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Secondary outcome [2]
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Time to Clinical Resolution
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Assessment method [2]
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Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.
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Timepoint [2]
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28 days
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Secondary outcome [3]
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Number of Participants With Clinical Resolution
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Assessment method [3]
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Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.
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Timepoint [3]
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28 days
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Secondary outcome [4]
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Time to Alleviation of Symptoms
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Assessment method [4]
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Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.
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Timepoint [4]
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28 days
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Secondary outcome [5]
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Time to Resolution of Fever
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Assessment method [5]
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Time to resolution of fever was the number of hours from initiation of study treatment until temperature was =37.2°C/=99°F oral or =37.8°C/=100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.
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Timepoint [5]
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28 days
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Secondary outcome [6]
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Time to Resumption of Usual Activities
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Assessment method [6]
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Subject's ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.
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Timepoint [6]
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28 days
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Secondary outcome [7]
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Time to Hospital Discharge
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Assessment method [7]
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Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.
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Timepoint [7]
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28 days
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Secondary outcome [8]
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Number of Participants Experiencing Influenza-related Complications
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Assessment method [8]
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Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.
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Timepoint [8]
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28 days
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Secondary outcome [9]
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Number of Participants Admitted to ICU After Initiation of Treatment
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Assessment method [9]
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The number of subjects experiencing ICU admission after initiation of treatment.
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Timepoint [9]
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28 days
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Secondary outcome [10]
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Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)
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Assessment method [10]
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The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment
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Timepoint [10]
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28 days
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Secondary outcome [11]
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Survival (Kaplan-Meier Estimates)
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Assessment method [11]
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Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.
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Timepoint [11]
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14 and 28 days
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Eligibility
Key inclusion criteria
- Male and non-pregnant female subjects 6 years of age or older.
- Able to provide written informed consent, or for whom written consent may be provided
by a parent guardian or legally authorized representative, unless consent provided by
a parent, guardian or legally authorized representative is not consistent with
applicable local or ethical procedures, directives and /or guidelines.
- Presence of clinical signs and/or symptoms consistent with an acute illness compatible
with influenza infection; a measured temperature of = 38.0°C (100.4°F) oral, or =
38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following:
rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can include
fever meeting the above criteria as reported by the subject or their parent, guardian
or legally authorized representative in the 24 hours prior to Screening. The
requirement for fever is waived for any subject with influenza infection already
confirmed by laboratory tests (including Rapid Antigen Tests).
- Confirmation of influenza A or B infection in the local community by one of the
following means:
- the institution's local laboratory,
- the local public health system
- the national public health system
- a laboratory of a recognized national or multinational influenza surveillance scheme.
- Severity of illness requiring or anticipated to require in-hospital care.
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who have been hospitalized for greater than 24 hours (not including time
spent in the emergency department).Blood platelet count of < 20 x 109/L.
- Serum bilirubin > 6 mg/dL at time of Screening evaluation.
- Serum ALT or AST > 5 X upper limit of normal at time of Screening evaluation.
- Serum creatinine > 5.0 mg/dL at time of Screening evaluation.
- Subjects who require peritoneal dialysis or hemofiltration.
- Altered neurologic status as defined by a Glasgow Coma Score of = 9, unless medically
induced.
- Females who are pregnant (positive urine or serum pregnancy test at Screening
evaluation) or breastfeeding.
- Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy.
(Subjects who have completed treatment 30 days prior to enrollment are allowed to
enroll in the study. Hormone treatment for cancer is also acceptable).
- Prior hematopoietic stem cell transplantation or solid organ transplant during the
previous 4 months.
- HIV infection with a known CD4 count < 200 cells/ mm3 unless on a stable highly active
antiretroviral (HAART) regimen for at least 6 months.
- Presence of a preexisting chronic infection that is undergoing or requiring medical
therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C
not requiring treatment are not excluded).
- Presence of any preexisting illness that, in the opinion of the Investigator, would
place the subject at an unreasonably increased risk through participation in this
study.
- Participation as a subject in any study of an experimental treatment for any condition
within the 30 days prior to the time of the Screening evaluation.
- Subjects diagnosed with cystic fibrosis.
- Subjects with confirmed clinical evidence of acute non-influenzal infection at the
time of Screening.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
234
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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- Brisbane
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Recruitment hospital [2]
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- Cairns
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Recruitment hospital [3]
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- Southport
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Recruitment hospital [4]
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- Clayton
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Recruitment hospital [5]
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- Melbourne
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Recruitment hospital [6]
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- Parkville
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment postcode(s) [2]
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- Cairns
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Recruitment postcode(s) [3]
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- Southport
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Melbourne
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Arkansas
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United States of America
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California
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United States of America
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State/province [4]
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Colorado
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Country [5]
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United States of America
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State/province [5]
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District of Columbia
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Country [6]
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United States of America
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State/province [6]
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Florida
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Country [7]
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United States of America
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State/province [7]
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Georgia
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Country [8]
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United States of America
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State/province [8]
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Hawaii
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Idaho
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Country [10]
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United States of America
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State/province [10]
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Illinois
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United States of America
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Indiana
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Country [12]
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United States of America
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Kansas
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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New York
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Ohio
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South Dakota
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Texas
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Washington
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Wisconsin
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Canada
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Edmonton
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Mexico
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AGS
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Mexico
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DF
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Mexico
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JAL
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Mexico
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NL
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Mexico
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SLP
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Mexico
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Durango
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New Zealand
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Wellington
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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New Zealand
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Tauranga
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Puerto Rico
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State/province [52]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BioCryst Pharmaceuticals
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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Department of Health and Human Services
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and
tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected
influenza infection.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00957996
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Contact person for public queries
Name
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00957996
Download to PDF