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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

February 14, 2018

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2019

Conditions
HemophiliaMenstrual Flow Excessive
Interventions
DRUG

Recombinant FVIII Fc fusion product Eloctate

Subjects will get FVIII activity corrected from the baseline level to 100-150% with Eloctate on the first day of menstruation at the beginning of the study interventional phase. The first dose of the drug will be given in the clinics via slow injection into a vein (infusion). A short assessment of pharmacokinetics (PK) (4 time-points blood draw: 15 min, 2 hours, 4 hours, 20 hours after the infusion) will be performed to assist with subsequent dosing. 2 total doses of Eloctate likely to be given on day 1 and 3 of menstrual period. The subject will then receive three additional PK-adjusted monthly doses of Eloctate (with no less than 21 days interval).

DRUG

Recombinant FIX Fc fusion product Alprolix

Subjects will get FIX activity corrected from the baseline level to 100-150% with Alprolix on the first day of menstruation at the beginning of the study interventional phase. The first dose of the drug will be given in the clinics via slow injection into a vein (infusion). A short assessment of pharmacokinetics (PK) (4 time-points blood draw: 15 min, 4 hours, 48 hours, 72 hours after the infusion) will be performed (by home nursing or local lab) to assist with subsequent dosing. Single dose of Alprolix likely to be given on day 1 of menstrual period. The subject will then receive three additional PK-adjusted monthly doses of Alprolix (with no less than 21 days interval).

DEVICE

Patient-operated diagnostic device for anemia AnemoCheck.

Each AnemoCheck test kit enables patients to check hemoglobin levels by pricking their finger to draw 5 μL of blood into a capillary tube, inserting that tube into a larger tube with a pre-filled chemical solution, mixing, waiting one minute, and assessing the color change of the solution using a reference color scale card included with the kit. The test is able to subjectively differentiate low, medium and high levels of hemoglobin to diagnose anemia at home. Study participants are taught to perform a hemoglobin check every other day using Anemocheck during 2 consecutive menstrual cycles. In addition they will have hemoglobin level obtained locally (LabCorp) drawn within 4-6 hours for comparison and correlation.

Trial Locations (1)

30322

Emory University Hospital Clinical Research Network, Atlanta

Sponsors
All Listed Sponsors
collaborator

Bioverativ Therapeutics Inc.

INDUSTRY

lead

Emory University

OTHER

NCT03272568 - Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers | Biotech Hunter | Biotech Hunter