Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04057040
Study type	Interventional
Source	Protagonist Therapeutics, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	October 1, 2019
Completion date	January 1, 2026

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See also
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