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Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05210790
Study type Interventional
Source Protagonist Therapeutics, Inc.
Contact Study Director
Phone 1-888-899-1543
Email [email protected]
Status Recruiting
Phase Phase 3
Start date April 1, 2022
Completion date June 2025

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