Study Evaluating rFIX; BeneFIX® in Hemophilia B

Wyeth is now a wholly owned subsidiary of Pfizer23 enrolled

Overview

The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemophilia B

Interventions

rFIXDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hemophilia B (FIX:C less than 2%) * Previous treatment of at least 150 exposure days using any FIX product * 12 years of age and older Exclusion Criteria: * The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient) * Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins * Patient has a genetic coagulation disorder other than hemophilia B

Locations (7)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Aurora, Colorado, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

New Brunswick, New Jersey, United States

Data from ClinicalTrials.gov

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