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Completed

NCT Number: NCT01154231

BeneFIX 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.

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Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nonacog Alfa (Genetical Recombination)

Drug

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 names: BeneFIX

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

BENEFIX(REGISTERED) INTRAVENOUS 500 1000 2000 DRUG USE RESULTS SURVEY (ALL-CASE SURVEILLANCE)

Important dates

Study start
2009
Primary completion
2014
Study completion
2017
First posted
Jun 30, 2010
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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