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Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04057040•Protagonist Therapeutics, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (16)

Mayo Clinic - Mayo Clinic Hospital

Phoenix, Arizona, United States

Marin Cancer Care

Greenbrae, California, United States

Stanford University

Palo Alto, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Kansas

Westwood, Kansas, United States

Pontchartrain Cancer Care

Covington, Louisiana, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Mount Sinai

New York, New York, United States

Key Dates

Start Date

October 1, 2019

Primary Completion Date

February 14, 2023

Completion Date

June 17, 2024

Last Updated

August 7, 2025

Enrollment

ACTUAL participants

Conditions

Polycythemia Vera

Interventions

PTG-300

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

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