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A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

This study has been terminated.
(This study was terminated for futility)
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00958776
First received: August 12, 2009
Last updated: January 28, 2015
Last verified: January 2015
Results First Received: January 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cough
Sore Throat
Nasal Congestion
Headache
Fever
Seasonal Influenza
Interventions: Drug: Peramivir+SOC
Drug: Placebo+SOC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo+SOC Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Peramivir+SOC

Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.


Participant Flow:   Overall Study
    Placebo+SOC   Peramivir+SOC
STARTED   137   268 
COMPLETED   121   239 
NOT COMPLETED   16   29 
Adverse Event                0                1 
Physician Decision                1                0 
Lost to Follow-up                2                6 
Withdrawal by Subject                7                16 
Protocol Violation                1                1 
Death                2                1 
Noncompliance; Protocol Deviations                2                3 
Missing                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled subjects

Reporting Groups
  Description
Placebo+SOC Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Peramivir+SOC

Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Total Total of all reporting groups

Baseline Measures
   Placebo+SOC   Peramivir+SOC   Total 
Overall Participants Analyzed 
[Units: Participants]
 137   268   405 
Age 
[Units: Years]
Mean (Full Range)
 43 
 (7 to 92) 
 47 
 (6 to 92) 
 46 
 (6 to 92) 
Age, Customized [1] 
[Units: Participants]
     
Children 6-11 Years   2   2   4 
Adolescents 12-17 Years   4   7   11 
Adults 18-24 Years   23   33   56 
Adults 25-34 Years   23   40   63 
Adults 35-44 Years   21   44   65 
Adults 45-54 Years   27   44   71 
Adults 55-64 Years   17   45   62 
Adults 65-74 Years   11   25   36 
Adults ≥ 75 Years   9   28   37 
[1] There were no subjects 6-11 years of age in the ITTI population.
Gender 
[Units: Participants]
     
Female   67   132   199 
Male   70   136   206 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   31   52   83 
White   71   169   240 
Black, of African Heritage or African American   23   28   51 
Native Hawaiian or Other Pacific Islander   1   1   2 
Other   11   18   29 
Body mass index (BMI) 
[Units: Kg/m^2]
Mean (Full Range)
 27.7 
 (15.2 to 59.9) 
 27.5 
 (12.3 to 66.0) 
 27.6 
 (12.3 to 66.0) 
Supplemental oxygen required at Screening 
[Units: Participants]
     
Needed   45   87   132 
Not needed   89   177   266 
Missing   3   4   7 
ICU admission at Baseline 
[Units: Participants]
     
Admitted   17   33   50 
Not admitted   117   231   348 
Missing   3   4   7 
Influenza Vaccination Status 
[Units: Participants]
     
Not vaccinated this year   111   226   337 
Vaccinated this year   26   41   67 
Missing   0   1   1 
Duration of Illness 
[Units: Participants]
     
≤ 48 hours   75   150   225 
> 48 hours   62   118   180 
Standard of Care Received (CRF) 
[Units: Participants]
     
NAI-Containing Antiviral Therapy   89   179   268 
Non-NAI-Containing Antiviral Therapy   9   7   16 
Supportive Care/No Antiviral Therapy   39   82   121 
Absolute Lymphocyte Count at Baseline 
[Units: Cell count]
Mean (Standard Deviation)
 1.3  (1.25)   1.3  (1.52)   1.3  (1.44) 
Chest X-ray at Screening 
[Units: Participants]
     
Normal   88   148   236 
Abnormal   49   120   169 


  Outcome Measures
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1.  Primary:   Time to Clinical Resolution (Kaplan-Meier Estimate)   [ Time Frame: 10 days ]

2.  Secondary:   Change (Reduction) in Influenza Virus Titer   [ Time Frame: Baseline and 24, 48, 108 hours ]

3.  Secondary:   Time to Alleviation of Clinical Symptoms of Influenza   [ Time Frame: 10 days ]

4.  Secondary:   Time to Resolution of Fever (Kaplan-Meier Estimate)   [ Time Frame: 10 days ]

5.  Secondary:   Time to Resumption of Usual Activities   [ Time Frame: 10 days ]

6.  Secondary:   Number of Subjects With ICU Admission   [ Time Frame: 10 days ]

7.  Secondary:   Duration of All ICU Admissions (Kaplan-Meier Estimate)   [ Time Frame: 10 days ]

8.  Other Pre-specified:   Time to Hospital Discharge   [ Time Frame: 10 days ]

9.  Other Pre-specified:   Incidence of Influenza-Related Complications   [ Time Frame: 10 days ]

10.  Other Pre-specified:   Number of Subjects Requiring More Than 5 Days of Study Drug   [ Time Frame: 10 days ]

11.  Other Pre-specified:   Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)   [ Time Frame: 28 days ]

12.  Other Pre-specified:   Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)   [ Time Frame: Initial (baseline or post-baseline) and up to 10 days ]

13.  Other Pre-specified:   Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial   [ Time Frame: Initial (baseline or post-baseline) and up to 10 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Interim analysis of the primary efficacy endpoint (time to clinical resolution) performed after the end of the 2012 Southern Hemisphere influenza season lead to study termination for futility. Final enrollment was ~70% of the planned enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William P. Sheridan, MBBS
Organization: BioCryst Pharmaceuticals, Inc.
phone: 919-859-1302


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00958776     History of Changes
Other Study ID Numbers: BCX1812-301
Study First Received: August 12, 2009
Results First Received: January 16, 2015
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration