Post Marketing Observational Study of Reformulated BeneFIX

NCT ID: NCT00835068

Last Updated: 2014-09-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-10-31

Brief Summary

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The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.

Detailed Description

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No sampling

Conditions

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Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BeneFIX

No intervention

Intervention Type OTHER

As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician

Interventions

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No intervention

As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
* Subjects who have dated and signed the informed consent form.

Exclusion Criteria

* Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
* Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chamberry, Cedex, France

Site Status

Pfizer Investigational Site

Le Chesnay, Cedex, France

Site Status

Pfizer Investigational Site

Caen, , France

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Pfizer Investigational Site

Clermont-Ferrand, , France

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Pfizer Investigational Site

Dijon, , France

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Pfizer Investigational Site

leKremlin-Bicetre, , France

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Pfizer Investigational Site

Lyon, , France

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Pfizer Investigational Site

Marseille, , France

Site Status

Pfizer Investigational Site

Montmorency, , France

Site Status

Pfizer Investigational Site

Montpellier, , France

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Pfizer Investigational Site

Nantes, , France

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Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Rouen, , France

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Pfizer Investigational Site

Saint-Priest-en-Jarez, , France

Site Status

Pfizer Investigational Site

Tours, , France

Site Status

Pfizer Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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B1821007

Identifier Type: -

Identifier Source: secondary_id

3090X1-4409

Identifier Type: -

Identifier Source: org_study_id

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