Status:
COMPLETED
Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to ...
Detailed Description
Phase 2 study in approximately sixty subjects previously diagnosed with Polycythemia Vera who require phlebotomy on a routine basis. There is a 28 week dose finding phase to identify a dose that maint...
Eligibility Criteria
Inclusion
- Main All subjects must meet ALL of the following inclusion criteria to be enrolled.
- Male and female subjects aged 18 years or older.
- Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera.
- Records of all phlebotomies performed for at least 28 weeks (preferably up to 52 weeks) before dosing are available.
- Subjects who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy.
- Subjects receiving cytoreductive therapy with hydroxyurea, interferon, or ruxolitinib must have received cytoreductive therapy for at least 24 weeks and be on a stable dose or have a decreasing dose (Medical Monitor approval required) for at least 8 weeks before dosing and with no planned change in dose.
- Main
Exclusion
- Subjects must meet NONE of the following exclusion criteria to be enrolled:
- Active or chronic bleeding within 4 weeks of screening.
- Meets the criteria for post-PCV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
- Known primary or secondary immunodeficiency.
- Any surgical procedure requiring general anesthesia within 1 month prior to screening or planned elective surgery during the study.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04057040
Start Date
October 1 2019
End Date
June 17 2024
Last Update
August 7 2025
Active Locations (16)
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1
Mayo Clinic - Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Marin Cancer Care
Greenbrae, California, United States, 94904
3
Stanford University
Palo Alto, California, United States, 94304
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612