Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01335061
First received: March 30, 2011
Last updated: May 12, 2015
Last verified: May 2015
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hemophilia B
Intervention: Biological: Nonacog alfa

  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
Participation included 25 enrolled participants from 15 study centers and 9 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The duration of participation was approximately 86 weeks, consisting of a Screening period (1 day to 4 weeks), Period 1 (on-demand treatment for 26 weeks), Period 2 (prophylaxis therapy for 52 weeks), and a follow-up safety period (4 weeks).

Reporting Groups
  Description
All Participants The data for all the participants is presented.

Participant Flow:   Overall Study
    All Participants  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
All Participants The data for all the participants is presented.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  25  
Age  
[units: Years]
Mean (Standard Deviation)
  31.3  (12.6)  
Gender  
[units: Participants]
 
Female     0  
Male     25  



  Outcome Measures
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1.  Primary:   Annualized Number of Bleeding Episodes.   [ Time Frame: 2 years ]

2.  Secondary:   Response to On-Demand Treatment for All Bleeding Episodes.   [ Time Frame: 2 years ]

3.  Secondary:   Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.   [ Time Frame: 2 years ]

4.  Secondary:   Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.   [ Time Frame: 2 years ]

5.  Secondary:   Average Infusion Dose.   [ Time Frame: 2 years ]

6.  Secondary:   Total Factor Consumption.   [ Time Frame: 2 years ]

7.  Secondary:   Incidence of Less Than Expected Therapeutic Effect (LETE)   [ Time Frame: 2 years ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01335061     History of Changes
Other Study ID Numbers: B1821010, 3090A1-3306, 2011-000520-15
Study First Received: March 30, 2011
Results First Received: March 18, 2015
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration