BeneFIX Drug Use Results Survey [All-Case Surveillance]

Brief Title

BeneFIX Drug Use Results Survey [All-Case Surveillance]

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.

        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.

Detailed Description

      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."

Study Type

Observational

Primary Outcome

Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy

Secondary Outcome

 Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes

Condition

Hemophilia B

Intervention

Nonacog Alfa (Genetical Recombination)

Study Arms / Comparison Groups

 Nonacog Alfa (Genetical Recombination)

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

February 2010

Completion Date

February 27, 2017

Primary Completion Date

August 2014

Eligibility Criteria

        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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, ,

Location Countries

Japan

Location Countries

Japan

Administrative Informations

NCT ID

NCT01154231

Organization ID

3090X1-4415

Secondary IDs

B1821004

Responsible Party

Sponsor

Study Sponsor

Pfizer

Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer

Verification Date

September 2018