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

Polycythemia Vera Clinical Trial

Official title: An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)

Status Enrolling by invitation

Clinical Trial 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 or Phase 3 study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

Clinical Trial Description

This is an open-label study designed to assess the long-term safety and efficacy of rusfertide. This study aims to provide long-term rusfertide treatment to subjects who complete dosing until the end-of-treatment of a previous Phase 2 or Phase 3 rusfertide study and are likely to continue benefiting from treatment with rusfertide based on their improved control of hematocrit levels <45% and reduced need for therapeutic phlebotomies. This study will provide long-term rusfertide treatment to these subjects and obtain data on safety and efficacy of long-term treatment with rusfertide. ;

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

• NCT number: NCT06033586
• Study type: Interventional
• Source: Protagonist Therapeutics, Inc.
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: January 22, 2024
• Completion date: April 1, 2027