NCT05210790

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Rusfertide	Experimental drug

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-02-21
• Completion: 2027-06-01
• First posted: 2022-01-27
• Last updated: 2025-08-07

Locations

184 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study