Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera

Inclusion Criteria

• Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 study of rusfertide.
• Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. Key

Exclusion Criteria

• Subject who, in the opinion of the investigator, should not participate in the study.
• Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study.
• Pregnant or lactating females.
• Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 30 days after the last dose of study drug.
• Men with partners of childbearing potential who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 90 days after the last dose of study drug.
• Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential.
• A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug.
• A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug.
• Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose.
• Subject with hypersensitivity to rusfertide or to any of the excipients.
• In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.