BeneFIX Drug Use Results Survey [All-Case Surveillance]

NCT01154231 | Completed Results

• 2 other identifiers: 3090X1-4415B1821009
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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. 1.Occurrence status of adverse events
2. 2.Factors that may influence the safety
3. 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.

Conditions

Hemophilia B

Keywords

BeneFIX Regulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes

  2 years for PTPs, 1 year for PUPs

Study Arms (1)

Nonacog Alfa (Genetical Recombination)

Drug: Nonacog Alfa (Genetical Recombination)

Interventions

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."

Also known as: BeneFIX

Nonacog Alfa (Genetical Recombination)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

You may qualify if:

• 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.

You may not qualify if:

• Patients not administered BeneFIX.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hemophilia B

Interventions

Factor IX

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: October 29, 2009
• Primary Completion: August 29, 2014
• Study Completion: February 27, 2017
• Last Updated: July 16, 2025
• Results First Posted: April 11, 2017

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)