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BeneFIX Drug Use Results Survey [All-Case Surveillance]

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ClinicalTrials.gov Identifier: NCT01154231
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Hemophilia B Drug: Nonacog Alfa (Genetical Recombination)

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
Actual Enrollment : 314 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)
Study Start Date : February 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Nonacog Alfa (Genetical Recombination) 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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154231


Locations
Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01154231     History of Changes
Other Study ID Numbers: 3090X1-4415
B1821004
B1821009 ( Other Identifier: Alias Study Number )
First Posted: June 30, 2010    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017

Keywords provided by Pfizer:
BeneFIX Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked