Clinical Trial: BeneFIX Drug Use Results Survey [All-Case Surveillance]
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)
Brief Summary:
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.
- Occurrence status of adverse events
- Factors that may influence the safety
- 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.
Detailed Summary:
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."
Sponsor: Pfizer
Current Primary Outcome:
- 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.
Original Primary Outcome: Number of times of dosing required for hemosbleeding episodes [ Time Frame: 2 years ]
Current Secondary Outcome: Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes [ Time Frame: 2 years for PTPs, 1 year for PUPs ]
Original Secondary Outcome: Subjective evaluation of each therapeutic administration for bleeding episodes [ Time Frame: 2 years ]
Information By: Pfizer
Dates:
Date Received: June 28, 2010
Date Started: February 2010
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017