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Abstracts P063

VERIFY: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera

Verstovek Srdan , Kuykendall Andrew T , Hoffman Ronald , Koschmieder Steffen , Passamonti Francesco , Valone Frank , Modi Nishit B , Khanna Sarita , O’Connor Paula G , Gupta Suneel K. and Kiladjian Jean-Jacques
University of Texas MD Anderson Cancer Center, Houston, Texas, USA; H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA; Tisch Cancer Institute, Icahn School of Medicine At Mount Sinai Medical Center, New York, New York, USA; RWTH Aachen University, Aachen, Germany; University of Insubria, Varese VA, Italy; Protagonist Therapeutics, Newark, California, USA; Université de Paris, INSERM, Hôpital Saint-Louis, Paris, France
Introduction:
Patients with polycythemia vera (PV) are treated with periodic therapeutic phlebotomy (TP) alone or in combination with cytoreductive therapies (CRT) to maintain hematocrit (HCT) 45%, thereby increasing their risk of thrombosis [Marchioli NEJM 2013]. Indeed, a study of more than 4,000 US patients with PV in 2018 and 2019 found that only 22% maintained HCT
The study is comprised of three parts:

Part 1a: 1:1 randomized, double-blind, placebo-controlled, add-on phase with parallel-groups lasting 32‚Äâweeks.
Methods:
VERIFY (NCT05210790) is a phase 3, multicenter, global, randomized trial comparing the efficacy and safety of rusfertide versus placebo when added to ongoing therapy for PV (ie, TP alone or with concurrent CRT)
Publisher
John Wiley & Sons; Hoboken, USA
Source Journal
American Journal of Hematology
E ISSN 1096-8652 ISSN 0361-8609

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