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A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients with Phlebotomy-Requiring Polycythemia Vera.
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.
1. Obtain a preliminary estimate of PTG-300s efficacy in phlebotomy-requiring polycythemia vera (PCV) subjects including changes in phlebotomy requirement and splenomegaly. 2. Assess the safety of PTG-300 in PCV subjects who are phlebotomy requiring.