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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

Short name THRIVE

NCTNCT06033586 (opens ClinicalTrials.gov in a new tab)Other idPTG-300-21
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
46 participants (actual)
Sponsor
Protagonist Therapeutics, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
22 Jan 2024
Primary completion
1 Apr 2026 (estimated)
Completion
1 Apr 2027 (estimated)
First posted
13 Sept 2023
Last update posted
6 Aug 2025
Conditions
Polycythemia Vera

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 3

    THRIVE

    NCT06033586

    22 Jan 2024 to est. 1 Apr 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Open-label rusfertideDrug

Arms1

  • Experimental

    Open-label rusfertide

    Open-label rusfertide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Hematocrit

    Time frame · 0-2 years

    Registry description

    Median hematocrit

  2. Phlebotomies

    Time frame · 0-2 years

    Registry description

    Number of phlebotomies

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 study of rusfertide. * Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. Key Exclusion Criteria: * Subject who, in the opinion of the investigator, should not participate in the study. * Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study. * Pregnant or lactating females. * Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 30 days after the last dose of study drug. * Men with partners of childbearing potential who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 90 days after the last dose of study drug. * Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential. * A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug. * A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug. * Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose. * Subject with hypersensitivity to rusfertide or to any of the excipients. * In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.

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