Clinical Trial 23103

• Overview

  Study Title:

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

  Summary:

  This is an open-label study designed to assess the long-term safety and efficacy of rusfertide.

  Objective:

  Objective: The purpose of this study is to determine the long-term safety, tolerability, and efficacy of rusfertide in subjects with polycythemia vera (PV).

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Rusfertide (PTG-300)

• Inclusion Criteria

  Inclusion Criteria:
  • Participant has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 or Phase 3 study of rusfertide.
  • Participant 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.

• Exclusion Criteria

  Exclusion Criteria:
  • Participant who, in the opinion of the investigator, should not participate in the study.
  • Participant who discontinued 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 (> Men with partners of childbearing potential who do not agree to use medically acceptable contraception (> 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 participant who 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 participant who 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.
  • Participant with hypersensitivity to rusfertide or to any of the excipients.
  • In the investigator's opinion, the participant has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.

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