Status:
COMPLETED
Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers
Lead Sponsor:
Emory University
Collaborating Sponsors:
Bioverativ Therapeutics Inc.
Conditions:
Hemophilia
Menstrual Flow Excessive
Eligibility:
FEMALE
14-55 years
Phase:
EARLY_PHASE1
Brief 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 hem...
Detailed Description
Hemophilia A or B is caused by defects in the factor VIII or IX gene, respectively, of which is located on the X chromosome. This disorder exhibits X-linked inheritance, in which primarily males, with...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03272568
Start Date
February 14 2018
End Date
December 31 2019
Last Update
May 18 2020
Active Locations (1)
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1
Emory University Hospital Clinical Research Network
Atlanta, Georgia, United States, 30322