Skip to content

Trial · Interventional

Active, not recruitingPhase 3Results postedRegistry data

A Study of Rusfertide in Adults With Polycythemia Vera (PV)

Short name VERIFY

NCTNCT05210790 (opens ClinicalTrials.gov in a new tab)Other idPTG-300-11Other id2023-509750-58-00Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
293 participants (actual)
Sponsor
Protagonist Therapeutics, Inc. · Industry
Design
Randomized · Triple masking
Countries
20 countries

United States, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Spain, Turkey (Türkiye), United Kingdom

Start
11 Apr 2022
Primary completion
21 Feb 2025
Completion
31 Aug 2028 (estimated)
First posted
27 Jan 2022
Last update posted
19 Oct 2026
Conditions
Polycythemia Vera

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202420262028
  1. Ph 3

    VERIFY

    NCT05210790

    11 Apr 2022 to est. 31 Aug 2028

Registry summary

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

Polycythemia vera (PV) is a long-term condition in which the bone marrow makes too many red blood cells (RBCs). Bone marrow is the soft tissue inside the large bones where blood cells are made. When there are too many RBCs, called erythrocytosis, the blood can become thicker and move less easily through blood vessels and organs. This can raise the risk of blood clots (thrombosis) in veins or arteries. Sometimes, these clots can be life-threatening and may cause a stroke or heart attack. Treatment aims to keep the percentage of RBCs in the blood (hematocrit) in a safe range. For adults with PV, this means keeping the hematocrit below 45%. This helps lower the blood thickness and the risk of thrombosis. PV can also be linked to low iron levels (iron deficiency), because the body uses iron to make more RBCs. Many people with PV are treated with blood removal (phlebotomy) to lower RBC levels in the blood. This can worsen the iron deficiency, because each blood removal also takes iron out of the body. Rusfertide is a medicine that lowers the amount of iron available in the blood. It works like hepcidin, a natural hormone that helps control iron levels in the body. By limiting iron available for RBC production, rusfertide may help keep hematocrit below 45% and may improve symptoms. It may also reduce, or even remove, the need for phlebotomy in people. The main aim of this study is to check how well rusfertide works compared with placebo to lower the number of phlebotomies. A placebo looks like rusfertide but does not have any medicine in it. Other aims are to learn how safe rusfertide is compared with placebo and to understand how well it works to reduce the need for phlebotomy and to keep hematocrit levels under control. The study also wants to learn how rusfertide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics or PD). This study has 4 parts that follow each other: * In part 1a, participants will receive either rusfertide or placebo. * In part 1b, all participants will receive rusfertide. * In part 2, participants can continue to receive rusfertide if they benefit from treatment with rusfertide. * Part 3 will include participants who finish Part 2 and still benefit from rusfertide. During the study, participants will visit the study clinical several times at fixed timepoints.

Interventions

  • RusfertideDrug
  • PlaceboDrug

Arms5

  • Placebo comparator

    Part 1a: Randomized, Double-Blind Period: Placebo

    Participants received their ongoing therapy for polycythemia vera (PV) along with rusfertide-matching placebo, subcutaneous (SC) injection, once weekly, from baseline up to Week 32.

  • Experimental

    Part 1a: Randomized, Double-Blind Period: Rusfertide

    Participants received their ongoing therapy for PV along with rusfertide once weekly, SC injection, from baseline up to Week 32. Rusfertide doses were titrated to maintain hematocrit less than (\<) 45 percent (%). The starting dose was 19 milligrams (mg). The doses that were administered to Part 1a participants were 9.5, 19, 28, 41, 54, 69 and 82 mg.

  • Experimental

    Part 1b: Open-Label Treatment Period: Rusfertide

    Participants received rusfertide once weekly, SC injection, from Weeks 32 to 52. Rusfertide doses were titrated to maintain hematocrit \< 45%. Participants who received rusfertide in Part 1a continued at their current dose unless dose adjustment was required. Participants who received placebo in Part 1a started rusfertide at 19 mg. The doses that were administered to Part 1b participants were 9.5, 19, 28, 41, 54, 69 and 82 mg.

  • Experimental

    Part 2: Long Term Extension Period: Rusfertide

    Participants received rusfertide once weekly, SC injection, from Weeks 52 to 156. Rusfertide doses were titrated to maintain hematocrit \< 45%. The doses that were administered to Part 2 participants were 9.5, 19, 28, 41, 54, 69, 82, 95 and 108 mg. For weekly doses greater than (\>) 90 mg, the dose of rusfertide was and will be divided into 2 doses administered 3 to 4 days apart.

  • Experimental

    Part 3: Treatment Extension Period: Rusfertide

    Participants will receive rusfertide once weekly, SC injection, from Week 156 to the end of the study (approximately 5 years). Rusfertide doses will be titrated to maintain hematocrit \< 45%. The doses that will be administered to Part 3 participants are 9.5, 19, 28, 41, 54, 69, 82, 95 and 108 mg. For weekly doses \> 90 mg, the dose of rusfertide will be divided into 2 doses administered 3 to 4 days apart.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Part 1a: Percentage of Participants Who Achieved Response

    Time frame · From Weeks 20 to 32

    Registry description

    Response was defined as absence of phlebotomy eligibility. Phlebotomy eligibility was defined as either: 1) A confirmed hematocrit (HCT) greater than or equal to (≥) 45% that was at least 3% higher than the baseline HCT, where confirmation was defined as 2 consecutive HCT assessments that were ≥ 45% and at least 3% higher than the baseline HCT, or 2) HCT ≥ 48%.

Secondary outcomes(20)

  1. Part 1a: Number of Phlebotomies

    Time frame · Baseline to Week 32

  2. Part 1a: Percentage of Participants With All Hematocrit Values < 45%

    Time frame · Baseline to Week 32

  3. Part 1a: Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a Total T-score

    Time frame · Baseline, Week 32

    Registry description

    The PROMIS Fatigue SF 8a T-score will be obtained via the item-response theory (IRT) response-pattern scoring approach using the PROMIS Scoring Service available at https://www.assessmentcenter.net/ac\_scoringservice. It is an National Institutes of Health (NIH)-developed fatigue survey of 8 items that asks the participant about fatigue experience and impact over the past 7 days. Each item will be scored on a 5-point Likert scale (1=never/not at all to 5=almost always/very much). Raw scores (range: 8-40) will be converted into standardized T scores (range: 34.1-80.9), with higher scores indicating greater fatigue severity. A negative change from baseline indicates an improvement.

  4. Part 1a: Change From Baseline in the Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0 Total Symptom Score-7 (TSS7) Items

    Time frame · Baseline, Week 32

    Registry description

    The MFSAF version 4.0 (v4.0) TSS7 is a questionnaire developed by the Patient-Reported Outcome (PRO) Consortium's Myelofibrosis Working Group that focuses on the 7 core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain. It includes 7 items on a 0 (absent) to 10 (worst imaginable) numeric rating scale. A higher score indicates worse symptoms. A negative change from baseline indicates an improvement.

  5. Part 1a: Change From Baseline in the PROMIS Fatigue Short Form 8a Total T-score Among Participants Who Have Moderate or Severe Symptoms at Baseline

    Time frame · Baseline, Week 32

    Registry description

    The PROMIS Fatigue SF 8a T-score will be obtained via the IRT response-pattern scoring approach using the PROMIS Scoring Service available at https://www.assessmentcenter.net/ac\_scoringservice. It is a National Institutes of Health (NIH)-developed fatigue survey of 8 items that asks the participant about fatigue experience and impact over the past 7 days. Each item will be scored on a 5-point Likert scale (1=never/not at all to 5=almost always/very much). Raw scores (range: 8-40) will be converted into standardized T scores (range: 34.1-80.9), with higher scores indicating greater fatigue severity. Moderate or severe symptoms are defined as a baseline PROMIS Fatigue SF 8aT-score \>/= 58.8. A negative change from baseline indicates an improvement.

  6. Part 1a: Change From Baseline in the MFSAF Total Symptom Score-4 Items (TSS4) Among Participants Who Have Moderate or Severe Symptoms at Baseline

    Time frame · Baseline, Week 32

    Registry description

    The MFSAF v4.0 is a questionnaire developed by the PRO Consortium's Myelofibrosis Working Group that focused on the 7 core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain. Items are scored on a 0 (absent) to 10 (worst imaginable) numeric rating scale. The MFSAF TSS4 is the sum of four items in the MFSAF (fatigue, itching \[pruritis\], night sweats, and abdominal discomfort). The weekly TSS4 will be calculated by averaging daily scores over a 7-day interval leading to Week 32 (inclusive). Moderate or severe symptoms are defined as a baseline MFSAF TSS4 \>/=9.1. A higher score indicates worse symptoms. A negative change from baseline indicates an improvement.

  7. Part 1a: Change From Baseline in the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Problems With Concentration Among Participants Who Have Moderate or Severe Symptoms at Baseline

    Time frame · Baseline, Week 32

    Registry description

    MPN-SAF is a 10-item questionnaire measurement tool for symptoms of MPNs. Moderate or severe symptoms are defined as baseline MPN-SAF problems with concentration ≥4. The descriptive analysis approach the distribution of the MPN-SAF problems with concentration at Baseline will be categorized using the Patient Global Impression of Severity (PGI-S). The response quartiles will be used to establish the recommended cut-off points for the MPN-SAF Problems with Concentration corresponding to "none" or "mild" versus "moderate or "severe" categories on the PGI-S.

  8. Part 1a: Percentage of Participants With a Meaningful Within-person Change at Week 32 in the PROMIS Fatigue SF 8a Total T-score Among Participants Who Have Moderate or Severe Symptoms at Baseline

    Time frame · At Week 32

    Registry description

    The PROMIS Fatigue SF 8a T-score will be obtained via the IRT response-pattern scoring approach using the PROMIS Scoring Service available at https://www.assessmentcenter.net/ac\_scoringservice. It is an NIH-developed fatigue survey of 8 items that asks the participant about fatigue experience and impact over the past 7 days. Each item will be scored on a 5-point Likert scale (1=never/not at all to 5=almost always/very much). Raw scores (range: 8-40) will be converted into standardized T scores (range: 34.1-80.9), with higher scores indicating greater fatigue severity. Moderate or severe symptoms are defined as a baseline PROMIS Fatigue SF 8aT-score \>/= 58.8.

  9. Part 1a: Percentage of Participants With a Meaningful Within-person Change at Week 32 in the MFSAF TSS4 Among Participants Who Had Moderate or Severe Symptoms at Baseline

    Time frame · At Week 32

    Registry description

    The MFSAF v4.0 is a questionnaire developed by the PRO Consortium's Myelofibrosis Working Group that focuses on the 7 core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain. It included 7 items on a 0 (absent) to 10 (worst imaginable) numeric rating scale. The MFSAF TSS4 is the sum of four items in the MFSAF (fatigue, itching \[pruritis\], night sweats, and abdominal discomfort). The weekly TSS4 will be calculated by averaging daily scores over a 7-day interval leading to Week 32 (inclusive). Moderate or severe symptoms are defined as a baseline MFSAF TSS4 \>/=9.1.

  10. Part 1a: Percentage of Participants With a Meaningful Within-person Change at Week 32 in the MPN-SAF Problems With Concentration Among Participants Who Had Moderate or Severe Symptoms at Baseline

    Time frame · At Week 32

    Registry description

    MPN-SAF is a 10-item questionnaire measurement tool for symptoms of MPNs. Moderate or severe symptoms are defined as baseline MPN-SAF problems with concentration ≥4. The descriptive analysis approach the distribution of the MPN-SAF problems with concentration at Baseline was categorized using the PGI-S. The response quartiles were used to establish the recommended cut-off points for the MPN-SAF Problems with Concentration corresponding to "none" or "mild" versus "moderate or "severe" categories on the PGI-S.

  11. Change From Baseline at Each Scheduled Assessment in Individual Questions and the Total Fatigue T-score Based on PROMIS Fatigue SF 8a

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    The PROMIS Fatigue SF 8a T-score will be obtained via the IRT response-pattern scoring approach using the PROMIS Scoring Service available at https://www.assessmentcenter.net/ac\_scoringservice. It is an NIH-developed fatigue survey that includes 8 items that asks the participant about fatigue experience and impact over the past 7 days. Each item will be scored on a 5-point Likert scale (1=never/not at all to 5=almost always/very much). Raw scores (range: 8-40) will be converted into standardized T scores (range: 34.1-80.9), with higher scores indicating greater fatigue severity.

  12. Change From Baseline at Each Scheduled Assessment in Individual Questions and the Total Fatigue T-score Based on PROMIS Fatigue Short Form 8a for Among Participants With Moderate or Severe Symptoms at Baseline

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    The PROMIS Fatigue SF 8a T-score was obtained via the IRT response-pattern scoring approach using the PROMIS Scoring Service available at https://www.assessmentcenter.net/ac\_scoringservice. It is a National Institutes of Health (NIH)-developed fatigue survey of 8 items that asks the participant about fatigue experience and impact over the past 7 days. Each item will be scored on a 5-point Likert scale (1=never/not at all to 5=almost always/very much). Raw scores (range: 8-40) will be converted into standardized T scores (range: 34.1-80.9), with higher scores indicating greater fatigue severity. Moderate or severe symptoms are defined as a baseline PROMIS Fatigue SF 8aT-score \>/= 58.8. A negative change from baseline indicates an improvement.

  13. Change From Baseline at Each Scheduled Assessment in Individual Symptom Score and the Total Score Based on MFSAF v4.0 TSS4

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    The MFSAF v4.0 is a questionnaire developed by the PRO Consortium's Myelofibrosis Working Group that focuses on the 7 core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain. It includes 7 items on a 0 (absent) to 10 (worst imaginable) numeric rating scale. A higher score indicates worse symptoms.

  14. Change From Baseline at Each Scheduled Assessment in Individual Symptom Score and the MFSAF v4.0 TSS4 Among Participants With Moderate or Severe Symptoms at Baseline

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    The MFSAF v4.0 is a questionnaire developed by the PRO Consortium's Myelofibrosis Working Group that focused on the 7 core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain. Items are scored on a 0 (absent) to 10 (worst imaginable) numeric rating scale. The MFSAF TSS4 is the sum of four items in the MFSAF (fatigue, itching \[pruritis\], night sweats, and abdominal discomfort). The weekly TSS4 will be calculated by averaging daily scores over a 7-day interval leading to Week 32 (inclusive). Moderate or severe symptoms are defined as a baseline MFSAF TSS4 \>/=9.1. A higher score indicates worse symptoms. A negative change from baseline indicates an improvement.

  15. Part 1a: Percentage of Participants With a Meaningful Within-person Change at Week 32 in the PROMIS Fatigue SF 8a Total T-score

    Time frame · At Week 32

    Registry description

    The PROMIS Fatigue SF 8a T-score will be obtained via the IRT response-pattern scoring approach using the PROMIS Scoring Service available at https://www.assessmentcenter.net/ac\_scoringservice. It is an NIH-developed fatigue survey that includes 8 items that asks the participant about fatigue experience and impact over the past 7 days. Each item will be scored on a 5-point Likert scale (1=never/not at all to 5=almost always/very much). Raw scores (range: 8-40) will be converted into standardized T scores (range: 34.1-80.9), with higher scores indicating greater fatigue severity. A negative change from baseline indicates an improvement.

  16. Part 1a: Percentage of Participants With a Meaningful Within-person Change at Week 32 in the MFSAF TSS4

    Time frame · At Week 32

    Registry description

    The MFSAF v4.0 is a questionnaire developed by the PRO Consortium's Myelofibrosis Working Group that focuses on the 7 core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain. It includes 7 items on a 0 (absent) to 10 (worst imaginable) numeric rating scale. The MFSAF TSS4 is the sum of four items in the MFSAF (fatigue, itching \[pruritis\], night sweats, and abdominal discomfort). The weekly TSS4 will be calculated by averaging daily scores over a 7-day interval leading to Week 32 (inclusive).

  17. Part 1a: Percentage of Participants With a Meaningful Within-person Change at Week 32 in the MPN-SAF Problems With Concentration

    Time frame · At Week 32

    Registry description

    MPN-SAF is a 10-item questionnaire measurement tool for symptoms of MPNs. Moderate or severe symptoms are defined as a baseline MPN-SAF problems with concentration ≥ 4. The descriptive analysis approach the distribution of the MPN-SAF problems with concentration at Baseline was categorized using the PGI-S. The response quartiles were used to establish the recommended cut-off points for the MPN-SAF Problems with Concentration corresponding to "none" or "mild" versus "moderate or "severe" categories on the PGI-S.

  18. Change From Baseline at Each Scheduled Assessment in Individual Symptom Score and the Total Score Based on MPN-SAF TSS 10

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    MPN-SAF is a 10-item questionnaire measurement tool for symptoms of MPNs. Moderate or severe symptoms are defined as a baseline MPN-SAF problems with concentration ≥ 4. The descriptive analysis approach the distribution of the MPN-SAF problems with concentration at Baseline was categorized using the PGI-S. The response quartiles were used to establish the recommended cut-off points for the MPN-SAF Problems with Concentration corresponding to "none" or "mild" versus "moderate or "severe" categories on the PGI-S.

  19. Change From Baseline in Patient Global Impression of Severity (PGI-S) at Each Scheduled Assessment

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    The PGI-S is a single question to assess the severity of PV symptoms over the last 24 hours prior to dosing. The participant will determine the severity of their PV symptoms on a 4-point scale ranging from "None" (0) to "Severe" (3). A higher score indicates worse symptoms. A negative change from baseline indicates an improvement.

  20. Percentage of Participants With at Least One Unit Improvement in the PGI-S From Baseline at Each Scheduled Assessment

    Time frame · Baseline to end of study (up to approximately 5 years)

    Registry description

    The PGI-S is a single question to assess the severity of PV symptoms over the last 24 hours prior to dosing. The participant will determine the severity of their PV symptoms on a 4-point scale ranging from "None" (0) to "Severe" (3). A higher score indicates worse symptoms. A negative change from baseline indicates an improvement.

Posted results

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

Primary outcome results

Primary outcomeNumber· From Weeks 20 to 32

Part 1a: Percentage of Participants Who Achieved Response

GroupValue (percentage of participants)
Part 1a: Randomized, Double-Blind Period: Placebo32.9
Part 1a: Randomized, Double-Blind Period: Rusfertide76.9
Secondary and other outcome results(7)
Secondary outcome· Baseline to Week 32

Part 1a: Number of Phlebotomies

GroupValue
Secondary outcome· Baseline to Week 32

Part 1a: Percentage of Participants With All Hematocrit Values < 45%

GroupValue
Secondary outcome· Baseline, Week 32

Part 1a: Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a Total T-score

GroupValue
Secondary outcome· Baseline, Week 32

Part 1a: Change From Baseline in the Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0 Total Symptom Score-7 (TSS7) Items

GroupValue
Secondary outcome· Baseline, Week 32

Part 1a: Change From Baseline in the PROMIS Fatigue Short Form 8a Total T-score Among Participants Who Have Moderate or Severe Symptoms at Baseline

GroupValue
Secondary outcome· Baseline, Week 32

Part 1a: Change From Baseline in the MFSAF Total Symptom Score-4 Items (TSS4) Among Participants Who Have Moderate or Severe Symptoms at Baseline

GroupValue
Secondary outcome· Baseline, Week 32

Part 1a: Change From Baseline in the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Problems With Concentration Among Participants Who Have Moderate or Severe Symptoms at Baseline

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part 1a: Randomized, Placebo-Controlled Period: PlaceboParticipants received their ongoing therapy for PV along with rusfertide-matching placebo, SC injection, once weekly, from baseline up to Week 32.0 / 1467 / 146101 / 146
Part 1a: Randomized, Placebo-Controlled Period: RusfertideParticipants received their ongoing therapy for PV along with rusfertide once weekly, SC injection from baseline up to Week 32. Rusfertide doses were titrated to maintain hematocrit \< 45%. The starting dose was 19 mg. The doses that were administered to Part 1a participants were 9.5, 19, 28, 41, 54, 69 and 82 mg.0 / 1475 / 145115 / 145
Part 1b: Open-Label Treatment PhaseParticipants received rusfertide once weekly, SC injection, from Weeks 32 to 52. Rusfertide doses were titrated to maintain hematocrit \< 45%. Participants who received rusfertide in Part 1a continued at their current dose unless dose adjustment was required. Participants who received placebo in Part 1a started rusfertide at 19 mg. The doses that were administered to Part 1b participants were 9.5, 19, 28, 41, 54, 69 and 82 mg.0 / 2747 / 274139 / 274
Part 2: Long Term ExtensionParticipants received rusfertide once weekly, SC injection, from Weeks 52 to 156. Rusfertide doses were titrated to maintain hematocrit \< 45%. The doses that were administered to Part 2 participants were 9.5, 19, 28, 41, 54, 69, 82, 95 and 108 mg. For weekly doses \> 90 mg, the dose of rusfertide was divided into 2 doses administered 3 to 4 days apart.0 / 26710 / 266104 / 266

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: 1. Male and female participants aged 18 (or the minimum country specific age of consent if greater than \[\>\]18) years or older. 2. Participant understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. 3. Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of PV. 4. Phlebotomy requiring defined as ALL of the following: 1. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization, and 2. Last phlebotomy due to inadequate hematocrit control within 3 months before randomization, and 3. No phlebotomy within 6 days prior to randomization (do not include day of phlebotomy and day of randomization in the 6-day count). 5. Complete blood count (CBC) values immediately prior to randomization: 1. Hematocrit \<45%, 2. White blood cell count (WBC) 4000 cells per microlitre (/μL) to 20,000/μL (inclusive), and 3. Platelets 100,000/μL to 1,000,000/μL (inclusive). 6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 7. Women of childbearing potential (WOCBP) agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 30 days after the last dose of study drug. 8. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study medication. 9. Men with partners of childbearing potential agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 90 days after the last dose of study drug. In addition, men must use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential. 10. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose. 11. Participants receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen as follows: 1. Hydroxyurea - at least 2 months 2. Janus kinase (JAK) inhibitor - at least 2 months 3. Interferon - at least 6 months. 12. Participants treated with phlebotomy alone at randomization must have stopped: 1. Hydroxyurea at least 2 months before screening 2. JAK inhibitor at least 2 months before screening 3. Interferon at least 6 months before screening. Exclusion criteria: 1. Clinically meaningful laboratory abnormalities at Screening, including but not limited to the following: 1. Estimated glomerular filtration rate (eGFR) \<15 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5×upper limit of normal (ULN) 3. Total bilirubin \>1.5×ULN 2. Participants who required phlebotomy at HCT levels lower than 45%. 3. Pregnant or lactating females. 4. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization. 5. Active or chronic bleeding within 2 months prior to randomization. 6. Met the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment. 7. Any infection requiring systemic therapy within 1 month of dosing except controlled human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. Prophylactic therapies were allowed. 8. Any serious or unstable medical condition (e.g., poorly controlled HIV infection) or uncontrolled psychiatric condition as judged by the Investigator that would impair the participant's ability to participate in the study. 9. Major surgical procedure within 2 months prior to randomization unless the participant had fully recovered from surgery or planned major elective surgery during the study. 10. History of invasive malignancies within the last 5 years, except 1. localized cured cancer (e.g., prostate cancer and cervical cancer) 2. localized cured in situ or Stage 1 squamous cell carcinoma (SCC) of the skin, basal cell carcinoma (BCC) of the skin, or in situ melanoma of the skin. 11. Participants with in situ or Stage 1 SCC of the skin, in situ or Stage 1 BCC of the skin, or in situ melanoma of the skin identified during the required dermatology examination at Screening unless the cancer was adequately treated (i.e., treatment that was expected to be curative, such as Mohs surgery) before randomization. Note: Suspicious lesions were to be biopsied and results made available before randomization. 12. Participants with active alcohol or drug addiction that would have interfered with their ability to comply with study requirements. 13. Participants who did not complete at least 4 days of MFSAF assessments within 1 week prior to randomization. 14. Receipt of an investigational agent within 2 months or 5 half-lives, whichever was longer, prior to randomization. 15. Received busulfan, pipobroman, or 32Phosphorus within 7 months prior to Screening. 16. Participants with hypersensitivity to rusfertide or to any of the excipients or placebo. 17. Participants with any lesion or mass detected by physical examination or imaging during screening that was suspicious for malignancy unless evaluated and assessed to be not malignant.

PepBank is a research reference. Talk to a doctor before you use any peptide.