Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 vis...
Detailed Description
This is an open-label study designed to assess the long-term safety and efficacy of rusfertide. This study aims to provide long-term rusfertide treatment to subjects who complete dosing until the end-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06033586
Start Date
January 22 2024
End Date
April 1 2027
Last Update
August 6 2025
Active Locations (1)
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1
Pontchartrain Cancer Care
Covington, Louisiana, United States, 70433