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Rusfertide for Polycythemia Vera (THRIVE Trial)

Phase 3
Waitlist Available
Research Sponsored by Protagonist Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 or Phase 3 study of rusfertide.
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying the safety and effectiveness of rusfertide in people with polycythemia vera. Participants who have already received rusfertide in a previous study and meet the criteria for

Who is the study for?
This trial is for people with Polycythemia Vera who have already been treated with rusfertide for at least 12 months in a previous Phase 2 or Phase 3 study. Participants must understand the study, be willing to follow its rules, and give written consent.
What is being tested?
The trial is testing the long-term safety and effectiveness of an open-label drug called rusfertide in patients with Polycythemia Vera. It's an extension for those who've completed prior rusfertide studies.
What are the potential side effects?
Specific side effects are not listed here, but since this is a safety study, it will monitor any adverse reactions from continued use of rusfertide over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed a year of rusfertide treatment and finished the final visit of a prior study.
Select...
This criterion is not clear enough to be translated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hematocrit
Phlebotomies

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label rusfertideExperimental Treatment1 Intervention
Open-label rusfertide

Find a Location

Who is running the clinical trial?

Protagonist Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
909 Total Patients Enrolled
3 Trials studying Polycythemia Vera
350 Patients Enrolled for Polycythemia Vera
~31 spots leftby Apr 2026
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