The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
The pivotal clinical data support prolonged dosing intervals of up to 14 days for routine
prophylaxis in hemophilia B patients. The majority of adult and pediatric patients using
Idelvion for routine prophylaxis had a median annualized spontaneous bleeding rate (AsBR) of
0.00. The majority (99%) of bleeding episodes were managed successfully with one or two
infusions, and 94% of bleeds were controlled with only one infusion regardless of the cause
or location.
The rationale for this study is to collect the effectiveness and safety data of severe
hemophilia B patients treated with Idelvion following institutional standard of care. It is
the aim of this study to extend the results of the clinical trial program to a broader
hemophilia B population, and to compare with current alternative factor IX treatments in
Taiwan.