Updated: Sep 29, 2020
The above PDF file is the study information that HemoAware Founder, Jesse John Francis Clark received prior to starting the BIVV001 study. The study is through Bioverativ Therapeutics, Inc. (A Sanofi Company)
Clark was on this study for 11 months until he was suddenly kicked out of his Hemophilia Treatment Center. Hemo Times has been instructed to release this information to the community regarding BIVV001.
Clark tells Hemo Times that, after he was kicked out of his HTC, he called Sanofi to see if they could send him an emergency supply of factor (Eloctate) to get him through the week until he found a PCP to get a perscription. Well, after a 30 minute phone call with Sanofi, Clark says they couldn't do anything for him. Clark was previously under the care of Amber Federizo at the Hemostasis & Thrombosis Center of Nevada (HTCNV).
So, Hemo Times has been instructed to release any and all information on the BIVV001 study.
BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels. The study is currently in Phase 3.
UPDATE: 9/29/2020: A representative from Sanofi emailed Hemo Times to "please" remove the leaked documents. HemoAware Founder, Jesse John Francis Clark, made a response video to Sanofi this morning.