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Trial · Interventional

CompletedPhase 2Registry data

Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

NCTNCT04057040 (opens ClinicalTrials.gov in a new tab)Other idPTG-300-04
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
70 participants (actual)
Sponsor
Protagonist Therapeutics, Inc. · Industry
Design
Randomized · Triple masking
Countries
2 countries

United States, India

Start
1 Oct 2019
Primary completion
14 Feb 2023
Completion
17 Jun 2024
First posted
14 Aug 2019
Last update posted
7 Aug 2025
Conditions
Polycythemia Vera

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022202320242025
  1. Ph 2

    Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

    NCT04057040

    1 Oct 2019 to 17 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PTG-300Drug
  • PlaceboDrug

Arms2

  • Experimental

    Dose finding PTG-300 (Part 1); PTG-300 (Part 2); Open label extension PTG-300 (Part 3)

  • Experimental

    Dose finding PTG-300 (Part 1); Placebo (Part 2); Open label extension PTG-300 (Part 3)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of responders during the blinded randomized withdrawal period (Week 29 to Week 41).

    Time frame · 12 weeks

    Registry description

    A subject will be considered a responder during the blinded randomized withdrawal phase if hematocrit control is maintained without phlebotomy eligibility. "Phlebotomy eligibility" is defined as any one of the following criteria being met: * hematocrit ≥45% that was ≥3% higher than Week 29 pre-randomization hematocrit value, or * hematocrit \>48%, or * an increase of ≥5% in hematocrit compared to Week 29 pre-randomization hematocrit value.

Secondary outcomes(4)

  1. Change in rate of phlebotomy events between Week 17 through Week 29 (inclusive; 12 weeks) compared to each subject's historical rate.

    Time frame · 12 weeks

  2. Change in rate of phlebotomy events between Week 1 through Week 29 (inclusive; 28 weeks) compared to each subject's historical rate.

    Time frame · 28 weeks

  3. Proportion of subjects achieving a response at Week 29, with response defined as having achieved the absence of "phlebotomy eligibility" during the efficacy evaluation phase beginning at Week 17 and continuing to Week 29.

    Time frame · 12 Weeks

    Registry description

    "Phlebotomy eligibility" in Part 1 is defined as a hematocrit ≥45% that was ≥3% higher than baseline level (defined as Part 1 pre-dose Day 1) or a hematocrit \>48%.

  4. Proportion of subjects with reduction in the rate of phlebotomy events beginning at the Week 17 visit and continuing to Week 29 (12 weeks) compared to each subject's historical rate.

    Time frame · 12 Weeks

    Registry description

    Time to "phlebotomy eligibility" from Week 29 to Week 41/End of Part 2.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

4 results

Rusfertide, a Hepcidin Mimetic, for Control of Erythrocytosis in Polycythemia Vera.

Kremyanskaya et al. 2024The New England journal of medicinecited by 46

PMID 38381675DOI 10.1056/nejmoa2308809PUB-38381675

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. 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. Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled: 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.

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