A Phase 3 interventional study of Placebo and Rusfertide in Polycythemia Vera, sponsored by Protagonist Therapeutics, Inc.. Active, not recruiting at 184 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Protagonist Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
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.
228 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's enrollment of 293 is above the median of 55 across 174 interventional studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Protagonist Therapeutics, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria.
CBC values immediately prior to randomization:
Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria.
Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
Drug: Rusfertide
Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
Drug: Placebo · Drug: Rusfertide
Placebo
Experimental drug
Proportion of subjects achieving a response who receive rusfertide compared to placebo.
Response is defined as absence of phlebotomy eligibility.
Time frame: Week 20 through Week 32
Comparison of mean number of phlebotomies between rusfertide and placebo.
Time frame: Week 0 to Week 32
Proportion of subjects with HCT values <45% for rusfertide and placebo.
Time frame: Week 0 to Week 32
Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
Time frame: Week 32
Comparison of mean change from baseline in total MFSAF total score.
Time frame: Week 32
Showing the first 100 of 184 sites across 20 countries.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Protagonist Therapeutics, Inc.