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.
NCT05210790
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