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Open-label 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

THRIVE 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.Check my eligibility

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.See study design

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.

THRIVE Trial 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.

THRIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hematocrit

Phlebotomies

THRIVE Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label rusfertideExperimental Treatment1 Intervention

Open-label rusfertide

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase for this investigation currently ongoing?

"Based on the information provided by clinicaltrials.gov, it appears that this particular trial is not currently accepting new patients. The initial posting date was January 22nd, 2024, and the most recent update occurred on January 23rd, 2024. However, there are presently 54 other ongoing studies actively recruiting participants at this time."

Answered by AI

Has rusfertide received official endorsement from the FDA in an Open-label format?

"Based on the team's assessment at Power, the safety of open-label rusfertide is rated as 3. This rating reflects that it is a Phase 3 trial with evidence supporting both efficacy and multiple rounds of data affirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033586.

All > Polycythemia Vera