A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Official Title

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

Summary:

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Trial Description

Primary Outcome:

  • Proportion of subjects achieving a response who receive rusfertide compared to placebo.
Secondary Outcome:
  • Comparison of mean number of phlebotomies between rusfertide and placebo.
  • Proportion of subjects with HCT values <45% for rusfertide and placebo.
  • Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
  • Comparison of mean change from baseline in total MFSAF total score.
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society