Study Evaluating rFIX; BeneFIX® in Hemophilia B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Hemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rFIX

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No