This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

BeneFIX Drug Use Results Survey [All-Case Surveillance]

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154231
First received: June 28, 2010
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: February 28, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hemophilia B
Intervention: Drug: Nonacog Alfa (Genetical Recombination)

  Participant Flow
  Hide Participant Flow

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
BeneFIX (Nonacog Alfa) Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.

Participant Flow:   Overall Study
    BeneFIX (Nonacog Alfa)
STARTED   314 
COMPLETED   312 
NOT COMPLETED   2 
Safety Unassessable, No Drug Admin.                1 
No Info. After 1st Day, No Drug Admin.                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
A total of 314 participants completed the study. Of the 314 participants, 2 participants were excluded from the baseline analysis. One was excluded due to no information after first day of treatment and no drug administration, the other due to safety not assessable and no drug administration.

Reporting Groups
  Description
BeneFIX (Nonacog Alfa) Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.

Baseline Measures
   BeneFIX (Nonacog Alfa) 
Overall Participants Analyzed 
[Units: Participants]
 312 
Age, Customized 
[Units: Participants]
 
<15 years   124 
≥15 years <65 years   179 
≥65 years   8 
Unknown   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4   1.3% 
Male      308  98.7% 
Previously Treated History [1] 
[Units: Participants]
 
PTPs   281 
PUPs   28 
Others   3 
[1] PTPs refer to previously treated patients. PUPs refer to previously untreated patients.
Severity [1] 
[Units: Participans]
 
Severe   156 
Moderate   98 
Mild   43 
Unknown   15 
[1] The severity of heamophilia B was defined as follows; severe, blood coagulation factor IX activity less than 1%; moderate, 1% to 5%; mild, more than 1%.
Number of Bleeding in the Past 1 Year 
[Units: Participants]
 
˂10 Times   194 
≥10 to ˂50 Times   73 
≥50 Times   8 
Unknown   37 
History of Inhibitor 
[Units: Participants]
 
Yes   6 
No   306 
Hemophilic Arthropathy 
[Units: Participants]
 
Yes   133 
No   179 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy   [ Time Frame: 2 years for PTPs, 1 year for PUPs ]

2.  Primary:   Number of Administrations Required for Hemostasis for Bleeding Events   [ Time Frame: 2 years for PTPs, 1 year for PUPs ]

3.  Secondary:   Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes   [ Time Frame: 2 years for PTPs, 1 year for PUPs ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01154231     History of Changes
Other Study ID Numbers: 3090X1-4415
B1821004
B1821009 ( Other Identifier: Alias Study Number )
Study First Received: June 28, 2010
Results First Received: February 28, 2017
Last Updated: February 28, 2017