Rusfertide for Polycythemia Vera
(THRIVE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Protagonist Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I completed a year of rusfertide treatment and finished the final visit of a prior study.

I understand the study, can follow its requirements, and agree to participate.

This criterion is not clear enough to be translated.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Open-label rusfertideExperimental Treatment1 Intervention

Open-label rusfertide