Open Accessibility Menu

Clinical Trial Information

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera
  • Category: Polycythemia Vera
  • Status: Active
  • Starts: Jul 21, 2023
  • Stage: III
  • Trial Number: PTG-300-11
  • Principal Investigator: Furhan Yunus, M.D.

    Research Nurse: Wendy Blount, RN, MSN

Description of Trial:

This study is intended to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera in maintaining hematocrit control.

Phase 3 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.

Please click here for additional information.