NCT06033586Active, not recruitingPhase 3
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 22 Jan 2024
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Protagonist Therapeutics, Inc.
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT06033586
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 46
- From 22 Jan 2024 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study.
- 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.
- In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.
Other illness
- 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.
- Subject with hypersensitivity to rusfertide or to any of the excipients.
Other
- Subject who, in the opinion of the investigator, should not participate in the study.
- Pregnant or lactating females.
- Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pontchartrain Cancer Care Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.