BeneFIX Drug Use Results Survey [All-Case Surveillance]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154231
First received: June 28, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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 Intervention
Hemophilia B
Drug: Nonacog Alfa (Genetical Recombination)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: All Cases Surveillance Of Japanese Hemophilia B Patients Receiving BeneFIX® (Nonacog Alfa, Recombinant Human Factor IX) For Usual Use

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of times of bleeding episodes during periodic replacement therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of times of dosing required for hemos bleeding episodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective evaluation of each therapeutic administration for bleeding episodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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."

  Eligibility

Ages Eligible for Study:   6 Months to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154231

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01154231     History of Changes
Other Study ID Numbers: 3090X1-4415, B1821004
Study First Received: June 28, 2010
Last Updated: September 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on September 16, 2014