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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
HHS 0100200700032C
Secondary ID [2] 0 0
BCX1812-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal Influenza 0 0
Cough 0 0
Sore Throat 0 0
Nasal Congestion 0 0
Myalgia 0 0
Headache 0 0
Fatigue 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Influenza Virus Titer (48 Hours)
Timepoint [1] 0 0
Baseline and 48 hours
Secondary outcome [1] 0 0
Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
Timepoint [1] 0 0
Baseline, 48, 108, 216 hours
Secondary outcome [2] 0 0
Time to Clinical Resolution
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Number of Participants With Clinical Resolution
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Time to Alleviation of Symptoms
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Time to Resolution of Fever
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Time to Resumption of Usual Activities
Timepoint [6] 0 0
28 days
Secondary outcome [7] 0 0
Time to Hospital Discharge
Timepoint [7] 0 0
28 days
Secondary outcome [8] 0 0
Number of Participants Experiencing Influenza-related Complications
Timepoint [8] 0 0
28 days
Secondary outcome [9] 0 0
Number of Participants Admitted to ICU After Initiation of Treatment
Timepoint [9] 0 0
28 days
Secondary outcome [10] 0 0
Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)
Timepoint [10] 0 0
28 days
Secondary outcome [11] 0 0
Survival (Kaplan-Meier Estimates)
Timepoint [11] 0 0
14 and 28 days

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.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Cairns
Recruitment hospital [3] 0 0
- Southport
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Cairns
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Parkville
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
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
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
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
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
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
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
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
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
South Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Manitoba
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Canada
State/province [40] 0 0
Saskatchewan
Country [41] 0 0
Canada
State/province [41] 0 0
Edmonton
Country [42] 0 0
Mexico
State/province [42] 0 0
AGS
Country [43] 0 0
Mexico
State/province [43] 0 0
DF
Country [44] 0 0
Mexico
State/province [44] 0 0
JAL
Country [45] 0 0
Mexico
State/province [45] 0 0
NL
Country [46] 0 0
Mexico
State/province [46] 0 0
SLP
Country [47] 0 0
Mexico
State/province [47] 0 0
Durango
Country [48] 0 0
New Zealand
State/province [48] 0 0
Wellington
Country [49] 0 0
New Zealand
State/province [49] 0 0
Christchurch
Country [50] 0 0
New Zealand
State/province [50] 0 0
Hamilton
Country [51] 0 0
New Zealand
State/province [51] 0 0
Tauranga
Country [52] 0 0
Puerto Rico
State/province [52] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioCryst Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Department of Health and Human Services
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00957996
Trial related presentations / publications
Ison MG, Fraiz J, Heller B, Jauregui L, Mills G, O'Riordan W, O'Neil B, Playford EG, Rolf JD, Sada-Diaz E, Elder J, Collis P, Hernandez JE, Sheridan WP. Intravenous peramivir for treatment of influenza in hospitalized patients. Antivir Ther. 2014;19(4):349-61. doi: 10.3851/IMP2680. Epub 2013 Aug 28.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00957996