drugset / Trial / NCT03272568

Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers

NCT03272568

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this feasibility study is to find out if two clotting factor products, Eloctate \[hemophilia A\] and Alprolix \[hemophilia B\], can reduce the amount of menstrual bleeding in female hemophilia A and B carriers (14 years of age or older) who have severe or heavy bleeding. These products are FDA-approved for use in males with hemophilia A and B to prevent and treat bleeding. They are not approved specifically to reduce menstrual bleeding, but may be useful for this purpose. Both products have an "extended half life" which means they circulate in the body longer than other FVIII or FIX products. The study team will gather additional information about the safety of these drugs and how well they work. The results of this feasibility study will provide information for an upcoming larger study.

Timeline

Start
2018-02-14
Primary completion
2019-12-31
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject EFTRENONACOG ALFA Protein / enzyme biologic Intravenous
Subject Efmoroctocog Alfa Protein / enzyme biologic Intravenous