Post Marketing Observational Study of Reformulated BeneFIX

This study is currently recruiting participants.

Verified by Wyeth, February 2009

First Received: February 2, 2009 Last Updated: February 24, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00835068

Purpose

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.

Condition
Hemophilia B

Genetics Home Reference related topics: hemophilia L1 syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post Marketing Observational Study of Reformulated BeneFIX

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety as measured by recording at each visit, any adverse effect for which the participating physician considers that a causal relationship with reformulated BeneFIX is possible. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Outcome assessed by i. # of bleeding episodes, # of injections and dose to stop bleeding, consumption of FIX during the observational period) ii. subjective assessment of efficacy by the physician and the patient [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	February 2009
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hemophilia B patients treated with reformulated BeneFIX

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835068

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

France
	Recruiting
Paris, France, 75015

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3090X1-4409
Study First Received:	February 2, 2009
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00835068 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Wyeth:

observational
post marketing study

Study placed in the following topic categories:

Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:

Hemophilia B
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 07, 2009