Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX|
- Number of Participants Reporting Efficacy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.
|Study Start Date:||April 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
The switch to BeneFIX has already been decided by the investigator. Patients will be followed up to 3 months after the switch.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749476
|Le kremlin Bicetre, France, 94275|
|Marseille, France, 13385|
|Montmorency, France, 95160|
|Montpellier, France, 34291|
|Paris, France, 75743|
|Rennes, France, 35033|
|Rouen, France, 76031|
|Tours, France, 37044|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|