Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
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  
Number of Participants  
[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  
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┬ácount]
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  
[1] There were no subjects 6-11 years of age in the ITTI population.



  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


No publications provided by BioCryst Pharmaceuticals

Publications automatically indexed to this study:

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