NCT04057040

Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	PTG-300	Active
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-02-14
• Completion: 2024-06-17
• First posted: 2019-08-14
• Last updated: 2025-08-07

Locations

16 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study