Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers
Hemophilia, Menstrual Flow Excessive
About this trial
This is an interventional treatment trial for Hemophilia focused on measuring Extended Life Plasma Derived Factor Products, Female hemophilia A and B carriers, Menorrhagia
Eligibility Criteria
Inclusion Criteria:
- Females of reproductive age who experience monthly menstrual bleedings
- Female Hemophilia A or B carrier (heterozygote, lyonized or Turner's Syndrome)
- FVIII or FIX activity ≤60% at time of the study
- Baseline Pictorial Bleeding Assessment Chart >150 mean at time of recruitment
- Negative pregnancy test at time of enrollment
- Both female and her male partner have agreed to use an acceptable barrier method of birth control (e.g., diaphragm, cervical cap, male condom, female condom, and spermicidal foam, sponges, and film) throughout the duration of this study (for sexually active participants)
Exclusion Criteria:
- Has not reached menarche
- Menopause: natural or induced by surgical/medical treatment
- Pregnant or breasfeeding
- Female or her male partner refuses to use barrier method of birth control (for sexually active)
- Current use of any of the following contraceptives (copper IUD, oral combined, Progestin-only including but not limited to: Provera, Aygestin, Nexplanon, Implanon, Depo Provera, Mirena IUD)
- VWF:Ag or VWF:RCo <40%
- Diagnosis of a qualitative platelet disorder
- Personal history of thrombosis or superficial thrombosis
- First degree relative with a history of thrombosis
- Personal history of concomitant bleeding or clotting disorder
- Cigarette smoker
- Willing to avoid taking an anti-fibrinolytic agent (amicar, transexamic acid, lysteda) during the trial
Sites / Locations
- Emory University Hospital Clinical Research Network
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Hemophilia A symptomatic female carriers
Hemophilia B symptomatic female carriers
Hemophilia A symptomatic female carriers with a baseline FVIII activity of ≤60% receive recombinant FVIII Fc fusion product Eloctate. Some of participants will be taught to perform a hemoglobin check using a patient-operated diagnostic device for anemia AnemoCheck every other day during 2 consecutive menstrual cycles.
Hemophilia B symptomatic female carriers with a baseline FIX activity of ≤60% receive recombinant FIX Fc fusion product Alprolix. Some of participants will be taught to perform a hemoglobin check using a patient-operated diagnostic device for anemia AnemoCheck every other day during 2 consecutive menstrual cycles.