Clinical Trial

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

Study acronym: THRIVE
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated August 6, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-09-05; most recent amendment 2025-08-04.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-08-04
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-01-23
Trial Details
NCT Number NCT06033586
Lead Sponsor Protagonist Therapeutics, Inc.
Conditions Polycythemia Vera
Enrollment 46 participants
Start Date 2024-01-22
Primary Completion 2026-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-06