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.
Summary:
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.
Click here to learn more about the VERIFY study.
Learn More
