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BeneFIX Drug Use Results Survey [All-Case Surveillance]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154231
First received: June 28, 2010
Last updated: May 22, 2013
Last verified: May 2013
History of Changes

June 28, 2010
May 22, 2013
February 2010
December 2017   (final data collection date for primary outcome measure)
  • Number of times of bleeding episodes during periodic replacement therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of times of dosing required for hemos bleeding episodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number of times of dosing required for hemosbleeding episodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01154231 on ClinicalTrials.gov Archive Site
Subjective evaluation of each therapeutic administration for bleeding episodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Subjective evaluation of each therapeutic administration for bleeding episodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BeneFIX Drug Use Results Survey [All-Case Surveillance]
All Cases Surveillance Of Japanese Hemophilia B Patients Receiving BeneFIX® (Nonacog Alfa, Recombinant Human Factor IX) For Usual Use

The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.

  1. Occurrence status of adverse events
  2. Factors that may influence the safety
  3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").

The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
Hemophilia B
Drug: Nonacog Alfa (Genetical Recombination)

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").

The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."

Other Name: BeneFIX
Nonacog Alfa (Genetical Recombination)
Intervention: Drug: Nonacog Alfa (Genetical Recombination)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
  • No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.

Exclusion Criteria:

  • Patients not administered BeneFIX.
Both
6 Months to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01154231
3090X1-4415, B1821004
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP