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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
June 28, 2010
February 28, 2017
February 2010
August 2014   (Final data collection date for primary outcome measure)
  • Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy [ Time Frame: 2 years for PTPs, 1 year for PUPs ]
    Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.
  • Number of Administrations Required for Hemostasis for Bleeding Events [ Time Frame: 2 years for PTPs, 1 year for PUPs ]
    Mean number of administrations for hemostasis in replacement therapy for bleeding events.
Number of times of dosing required for hemosbleeding episodes [ Time Frame: 2 years ]
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 for PTPs, 1 year for PUPs ]
Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.
Subjective evaluation of each therapeutic administration for bleeding episodes [ Time Frame: 2 years ]
Not Provided
Not Provided
 
BeneFIX Drug Use Results Survey [All-Case Surveillance]
Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)

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.
 
Completed
314
August 2014
August 2014   (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.
Not Provided
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01154231
3090X1-4415
B1821004
B1821009 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

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