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Post Marketing Observational Study of Reformulated BeneFIX

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: No intervention (Other)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

Official title: Post Marketing Observational Study Of Reformulated BeneFIX

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment

Number of Participants With Events of Special Interest

Secondary outcome:

Number of Bleeding Episodes

Number of Bleeding Episodes Requiring Treatment by Injection

Total Consumption of BeneFIX

Subjective Assessment of Efficacy by Participant

Dose Per Injection of BeneFIX

Subjective Assessment of Efficacy by Physician

Subjective Assessment of Ease of Use by Participant

Detailed description: No sampling

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Pfizer Investigational Site, Caen Cedex 9 14033, France

Pfizer Investigational Site, Clermont Ferrand 63003, France

Pfizer Investigational Site, Dijon Cedex 21070, France

Pfizer Investigational Site, leKremlin-Bicetre 94275, France

Pfizer Investigational Site, Lyon 69003, France

Pfizer Investigational Site, Marseille Cedex 05 13385, France

Pfizer Investigational Site, Montmorency 95160, France

Pfizer Investigational Site, Montpellier Cedex 5 34 34295, France

Pfizer Investigational Site, Nantes cedex 1 44093, France

Pfizer Investigational Site, Paris 75014, France

Pfizer Investigational Site, Paris F-75015, France

Pfizer Investigational Site, Rouen 76031, France

Pfizer Investigational Site, Saint Priest en Jarez 42277, France

Pfizer Investigational Site, Tours 37044, France

Pfizer Investigational Site, Vandoeuvre Les Nancy Cedex 54511, France

Pfizer Investigational Site, Chamberry, Cedex 73011, France

Pfizer Investigational Site, Le Chesnay, Cedex 78157, France

Additional Information

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

Starting date: January 2009
Last updated: September 11, 2014

Page last updated: August 20, 2015

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