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Study · Randomized controlled trial · n = 70 · 2024

4 results

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

Kremyanskaya M, Kuykendall AT, Pemmaraju N, Ritchie EK, Gotlib J, Gerds A, Palmer J, Pettit K, Nath UK, Yacoub A, Molina A, Saks SR and 7 more

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Modi NB, Valone FH, Khanna S, Gupta S, Verstovsek S, Ginzburg YZ, Hoffman R

The New England journal of medicine1 Feb 2024Cited by 46 (Europe PMC)

PMID38381675 (opens in a new tab)DOI10.1056/nejmoa2308809 (opens in a new tab)PepBankPUB-38381675
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In polycythemia vera, response occurred in 60% with rusfertide versus 17% with placebo during randomized withdrawal.

    In plain wordsIn polycythemia vera, 60% responded with rusfertide versus 17% with placebo during randomized withdrawal.

    Peptide
    Rusfertide
    Outcome
    IncreaseComposite response
    Study

    n = 59

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Blood counts and hematopoiesis · Cardiovascular
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Measurements

    Patients with response
    60%
    rusfertide, part 2 randomized withdrawal
    Patients with response
    17%
    placebo, part 2 randomized withdrawal
    P value
    0.002
    rusfertide versus placebo response

    Source sentences

    Summary
    During part 2, a response was observed in 60% of the patients who received rusfertide as compared with 17% of those who received placebo (P = 0.002).
    2 context sentences
    Summary · context
    Part 2 was a double-blind, randomized withdrawal period in which we assigned patients, in a 1:1 ratio, to receive rusfertide or placebo for 12 weeks.
    Summary · context
    The primary efficacy end point was a response, defined by hematocrit control, absence of phlebotomy, and completion of the trial regimen during part 2.
  2. 02HumanNon-randomized trialEfficacy outcome

    In polycythemia vera, estimated annual phlebotomies decreased from 8.7 to 0.6 during rusfertide dose finding versus pretreatment.

    In plain wordsIn polycythemia vera, estimated annual blood removal procedures decreased from 8.7 to 0.6 with rusfertide compared with pretreatment.

    Peptide
    Rusfertide
    Outcome
    DecreaseAnnual phlebotomy rate
    Study

    n = 70

    Comparator
    Pretreatment period
    Outcome group
    Blood counts and hematopoiesis · Cardiovascular
    Studied dose
    Dose not stated · 28 weeksAs given in this study (human).

    Measurements

    Phlebotomies per year (estimated mean)
    8.7 phlebotomies per year
    28 weeks before first dose; SD 2.9
    Phlebotomies per year (estimated mean)
    0.6 phlebotomies per year
    part 1 rusfertide dose finding; SD 1.0
    Estimated difference in phlebotomies per year
    8.1 phlebotomies per year
    before first dose versus part 1

    Source sentences

    Summary
    The estimated mean (±SD) number of phlebotomies per year was 8.7±2.9 during the 28 weeks before the first dose of rusfertide and 0.6±1.0 during part 1 (estimated difference, 8.1 phlebotomies per year).
    1 context sentence
    Summary · context
    In part 1 of the international, phase 2 REVIVE trial, we enrolled patients in a 28-week dose-finding assessment of rusfertide.
  3. 03HumanNon-randomized trialEfficacy outcome

    In polycythemia vera, mean maximum hematocrit was 44.5% during rusfertide dose finding versus 50.0% before treatment.

    In plain wordsIn polycythemia vera, mean maximum hematocrit was 44.5% with rusfertide versus 50.0% before treatment.

    Peptide
    Rusfertide
    Outcome
    DecreaseMaximum hematocrit
    Study

    n = 70

    Comparator
    Pretreatment period
    Outcome group
    Blood counts and hematopoiesis · Cardiovascular
    Studied dose
    Dose not stated · 28 weeksAs given in this study (human).

    Measurements

    Mean maximum hematocrit
    44.5%
    part 1 rusfertide dose finding; SD 2.2
    Mean maximum hematocrit
    50%
    28 weeks before first dose; SD 5.8

    Source sentences

    Summary
    The mean maximum hematocrit was 44.5±2.2% during part 1 as compared with 50.0±5.8% during the 28 weeks before the first dose of rusfertide.
    1 context sentence
    Summary · context
    In part 1 of the international, phase 2 REVIVE trial, we enrolled patients in a 28-week dose-finding assessment of rusfertide.
  4. 04HumanNon-randomized trialEfficacy outcome

    In patients with moderate or severe baseline polycythemia vera symptoms, rusfertide was associated with lower individual MPN-SAF symptom scores.

    In plain wordsIn polycythemia vera patients with moderate or severe initial symptoms, rusfertide was linked to lower symptom scores compared with baseline.

    Peptide
    Rusfertide
    Outcome
    DecreaseIndividual symptom scores
    Study

    n: not reported in source

    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · 28 weeksAs given in this study (human).

    Source sentences

    Summary
    Between baseline and the end of part 1, rusfertide treatment was associated with a decrease in individual symptom scores on the MPN-SAF in patients with moderate or severe symptoms at baseline.
    1 context sentence
    Summary · context
    In part 1 of the international, phase 2 REVIVE trial, we enrolled patients in a 28-week dose-finding assessment of rusfertide.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT04057040

Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

Protagonist Therapeutics, Inc.n = 701 Oct 2019 to 17 Jun 2024

Polycythemia Vera

Trial pageClinicalTrials.govUpdated 7 Aug 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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