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Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
Trial Status: complete
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 obtain preliminary evidence of efficacy of PTG-300 for the
treatment of phlebotomy-requiring polycythemia vera.
Inclusion Criteria
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria
to be enrolled.
1. Male and female subjects aged 18 years or older.
2. Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of
polycythemia vera.
3. Records of all phlebotomies performed for at least 28 weeks (preferably up to 52
weeks) before dosing are available.
4. 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.
5. 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 Criteria: Subjects must meet NONE of the following exclusion criteria to
be enrolled:
1. Active or chronic bleeding within 4 weeks of screening.
2. Meets the criteria for post-PCV myelofibrosis as defined by the International
Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
3. Known primary or secondary immunodeficiency.
4. Any surgical procedure requiring general anesthesia within 1 month prior to
screening or planned elective surgery during the study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04057040.
