Spots Global Cancer Trial Database for Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

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Trial Identification

Brief Title: Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

Official Title: A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Phlebotomy-Requiring Polycythemia Vera

Study ID: NCT04057040

Conditions

Polycythemia Vera

Interventions

PTG-300

Placebo

Study Description

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 obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.

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 maintains hematocrit \<45%. Subjects who successfully complete the dose finding phase will be entered into a 12 week randomized withdrawal phase to confirm the response. Subsequently patients will enter into an up to 3 year open label extension to investigate long term safety.