Protagonist Therapeutics is the sponsor.
Rusfertide, also called PTG-300, is an investigational medication. Study participation will help evaluate how safe and effective rusfertide is in keeping the hematocrit levels within the recommended range to reduce the need for phlebotomies.
VERIFY (NCT05210790) is a Phase 3 clinical study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis.
There is a 32-week period during which rusfertide or placebo will be added-on to each subject’s ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib.
All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.
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