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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00835068 |
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 |
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Hemophilia B |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Post Marketing Observational Study of Reformulated BeneFIX |
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) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Hemophilia B patients treated with reformulated BeneFIX
Inclusion criteria :
Exclusion criteria :
Contact: Trial Manager | clintrialparticipation@wyeth.com |
France | |
Recruiting | |
Paris, France, 75015 |
Study Director: | Medical Monitor | Wyeth |
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 |
observational post marketing study |
Hemophilia B Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Coagulation Disorders Hemophilia A Genetic Diseases, X-Linked Hemostatic Disorders |
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 |