BeneFIX Drug Use Results Survey [All-Case Surveillance]

Hemophilia B Clinical Trial

Official title:

Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154231
• Other study ID #: 3090X1-4415
• Secondary ID: B1821004B1821009
• Status: Completed
• Start date: February 2010
• Est. completion date: February 27, 2017

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: February 27, 2017
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia B

Intervention

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."

Locations

Country	Name	City	State
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy	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.	2 years for PTPs, 1 year for PUPs
Primary	Number of Administrations Required for Hemostasis for Bleeding Events	Mean number of administrations for hemostasis in replacement therapy for bleeding events.	2 years for PTPs, 1 year for PUPs
Secondary	Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes	Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.	2 years for PTPs, 1 year for PUPs

External Links

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