• Patient Stories
  • Understanding MPNs
    • Understanding MPNS
    • What Is Polycythemia Vera?
    • What Is Essential Thrombocythemia?
    • What Is Primary Myelofibrosis?
  • Resources
    • Empowered Patients
    • Dictionary
    • Resources
  • Partners
    • Industry Partners
    • International MPN Organizations
    • Partners
  • News Feed
  • Contact
  • MPN Search

PV Reporter

MPN Information and Research Hub

  • About
    • About Us
    • MPN Cancer Connection
    • Contact Us
  • MPN Specialists
  • Blog
  • Media
    • Podcast
      • 01: Polycythemia Vera Diagnosis, PV Reporter, Day 1, Doomsday or Living with a Plan
      • 02: MPN Chronicles – Interview with Dr. Pemmaraju
      • 03: Learn Benefits of Becoming your own MPN Advocate
      • 04: First Hematologist appointment for PV patient
      • 05: Tips to Living Well with an MPN
      • 06: My Plan to beat Coronavirus Blues
    • Videos
    • Dr. Interviews
      • Dr. Jean Jacques Kiladjian ASH 2018 RuxoPeg Phase 1/2 Trial of the Combo of Ruxolitinib and Pegasys in Myelofibrosis Patients
      • Dr. Michael Grunwald ASH 2018 Risk Assessment and Treatment Myelofibrosis Patients at Community Oncology Practices in the U.S.
      • Dr. J.J. Kiladjian ASH 2018 Headline Research Studies
      • ASH 2017 Interview with Dr. Michael Grunwald
        • ASH 2017 Interview with Dr. Raajit Rampal, part 1
        • ASH 2017 with Dr. Raajit Rampal, part 2
        • ASH 2017 Interview with Dr. Jean Jacques Kiladjian, part 1
        • ASH 2017 Interview with Dr. Jean Jacques Kiladjian, part 2
      • ASH 2016 Interviews
        • ASH 2016 Interview with Dr Kiladjian
        • ASH 2016 Interview with Dr Rampal
      • ASH 2015 Interviews
        • ASH 2015 Interview with Dr John Mascarenhas
        • ASH 2015 Interview with Dr Angela Fleischman
      • ASH 2014 Interviews
        • ASH 2014 Interview with Dr Heinz Gisslinger
        • ASH 2014 interview with Dr Richard Stone
  • Treatment
    • How I Treat MPN’s
    • Jakafi
    • INREBIC
    • Interferon treatment for MPNs
  • Support Group

Clinical Trial Finder

Search Results

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Study Purpose

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Main

Inclusion Criteria:

All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria.
  • - Male and female subjects aged 18 (or the country specific minimum age of consent >18) years or older.
  • - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera.
  • - At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization.
  • - CBC values immediately prior to randomization: 1.
Hematocrit <45%, 2. WBC 4000/μL to 20,000/μL (inclusive), and. 3. Platelets 100,000/μL to 1,000,000/μL (inclusive)
  • - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen.
  • - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
Main

Exclusion Criteria:

Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria.
  • - Clinically meaningful laboratory abnormalities at Screening.
  • - Subjects who require phlebotomy at hematocrit levels lower than 45%.
  • - Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
  • - Active or chronic bleeding within 2 months prior to randomization.
  • - History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer.
  • - Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization.
  • - Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05210790
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Protagonist Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Canada, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Poland, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Polycythemia Vera
Additional Details

Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.

Arms & Interventions

Arms

Experimental: Rusfertide

Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)

Experimental: Placebo

Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)

Interventions

Drug: - Placebo

Placebo

Drug: - Rusfertide

Experimental drug

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fresno, California

Status

Recruiting

Address

California Cancer Associates for Research and Excellence - Fresno

Fresno, California, 93720

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Marin Cancer Care, Greenbrae, California

Status

Recruiting

Address

Marin Cancer Care

Greenbrae, California, 94904

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

La Jolla, California

Status

Recruiting

Address

University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92037

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Los Angeles, California

Status

Recruiting

Address

University of California, Los Angeles (UCLA) - Medical Center

Los Angeles, California, 90095

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Stanford University, Palo Alto, California

Status

Recruiting

Address

Stanford University

Palo Alto, California, 94304

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Aurora, Colorado

Status

Recruiting

Address

University of Colorado - Aurora Cancer Center

Aurora, Colorado, 80045

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

BRCR Medical Center, Plantation, Florida

Status

Recruiting

Address

BRCR Medical Center

Plantation, Florida, 33322

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Northwest Oncology and Hematology, Rolling Meadows, Illinois

Status

Recruiting

Address

Northwest Oncology and Hematology

Rolling Meadows, Illinois, 60008

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Orchard Healthcare Research Inc, Skokie, Illinois

Status

Recruiting

Address

Orchard Healthcare Research Inc

Skokie, Illinois, 60046

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

University of Kansas Cancer Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Cancer Center

Kansas City, Kansas, 66160

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Bethesda, Maryland

Status

Recruiting

Address

American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)

Bethesda, Maryland, 20817

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Cancer Care Specialists, Reno, Nevada

Status

Recruiting

Address

Cancer Care Specialists

Reno, Nevada, 89511

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

New York, New York

Status

Recruiting

Address

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Gabrail Cancer Center, Canton, Ohio

Status

Recruiting

Address

Gabrail Cancer Center

Canton, Ohio, 44718

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Portland, Oregon

Status

Not yet recruiting

Address

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, Oregon, 97210

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

International Sites

One Clinical Research, Nedlands, Perth, Australia

Status

Recruiting

Address

One Clinical Research

Nedlands, Perth,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Medizinische Universitaet Graz, Graz, Austria

Status

Not yet recruiting

Address

Medizinische Universitaet Graz

Graz, , 8036

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Klinikum Wels-Grieskirchen Gmb, Wels, Austria

Status

Recruiting

Address

Klinikum Wels-Grieskirchen Gmb

Wels, , 4600

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Princess Margaret Hospital, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Hospital

Toronto, Ontario, M5G 2C4

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Fakultni nemocnice Brno, Brno, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Brno

Brno, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Fakultni nemocnice Olomouc, Olomouc, Czechia

Status

Recruiting

Address

Fakultni nemocnice Olomouc

Olomouc, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Vseobecna fakultni nemocnice v Praze, Praha, Czechia

Status

Not yet recruiting

Address

Vseobecna fakultni nemocnice v Praze

Praha, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

CHU Angers, Angers, Cedex 09, France

Status

Recruiting

Address

CHU Angers

Angers, Cedex 09,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

CHU Amiens Picardie - Hopital Sud, Amiens, France

Status

Recruiting

Address

CHU Amiens Picardie - Hopital Sud

Amiens, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Centre Hospitalier de Beziers, Béziers, France

Status

Recruiting

Address

Centre Hospitalier de Beziers

Béziers, , 34500

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

AP-HP Hopital Saint-Louis, Paris, France

Status

Recruiting

Address

AP-HP Hopital Saint-Louis

Paris, , 75010

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

HCL Centre Hospitalier Lyon Sud, Pierre-Bénite, France

Status

Recruiting

Address

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Aachen, Germany

Status

Recruiting

Address

Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)

Aachen, , 52074

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Universitaetsmedizin Greifswald, Greifswald, Germany

Status

Recruiting

Address

Universitaetsmedizin Greifswald

Greifswald, , 17489

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Queen Mary Hospital, Hong Kong, Hong Kong

Status

Recruiting

Address

Queen Mary Hospital

Hong Kong, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Semmelweis Egyetem, Budapest, Hungary

Status

Not yet recruiting

Address

Semmelweis Egyetem

Budapest, , 1085

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

Status

Not yet recruiting

Address

Debreceni Egyetem Klinikai Kozpont

Debrecen, , 4032

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hadassah Medical Center Ein Karem, Jerusalem, Israel

Status

Not yet recruiting

Address

Hadassah Medical Center Ein Karem

Jerusalem, , 121000

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Not yet recruiting

Address

Shaare Zedek Medical Center

Jerusalem, , 9103102

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 4428164

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel

Status

Not yet recruiting

Address

Rabin Medical Center, Beilinson Hospital

Petach Tikva, , 49100

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Shamir Medical Center (Assaf Harofe), Zerifin, Israel

Status

Recruiting

Address

Shamir Medical Center (Assaf Harofe)

Zerifin, , 70300

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Bologna, Italy

Status

Recruiting

Address

IRCCS Azienda Ospedaliero-Universtaria di Bologna

Bologna, , 40138

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Brescia, Italy

Status

Recruiting

Address

UOC Ematologia - ASST Spedail Civill Brescia

Brescia, , 25123

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Status

Recruiting

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Univ. A . Gemelli IRCCS

Roma, , 00168

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Varese, Italy

Status

Not yet recruiting

Address

Azienda ASST-SETTELAGHI, Ospedale di Circolo e Fond. Macchi di Varese Ospedael Vecchio

Varese, , 21100

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Brzozów, Poland

Status

Not yet recruiting

Address

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im.ks.B.Markiewicza, Oddzial

Brzozów, , 36-200

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland

Status

Recruiting

Address

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, , 85-065

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

MICS Centrum Medyczne Torun, Toruń, Poland

Status

Recruiting

Address

MICS Centrum Medyczne Torun

Toruń, , 87-100

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Łódź, Poland

Status

Not yet recruiting

Address

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Oddział

Łódź, , 93-510

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hospital Clinic Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic Barcelona

Barcelona, , 08036

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hospital Germans Trias i Pujol, Barcelona, Spain

Status

Recruiting

Address

Hospital Germans Trias i Pujol

Barcelona, , 08916

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hospital del Mar, Barcelona, Spain

Status

Recruiting

Address

Hospital del Mar

Barcelona, , 8003

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Madrid, Spain

Status

Recruiting

Address

Hospital General Universitario Gregorio Maranon

Madrid, , 28007

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hospital Universitari i Politecnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

Valencia, , 46026

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Hospital Quironsalud de Zaragoza, Zaragoza, Spain

Status

Recruiting

Address

Hospital Quironsalud de Zaragoza

Zaragoza, ,

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Pilgrim Hospital, Boston, United Kingdom

Status

Not yet recruiting

Address

Pilgrim Hospital

Boston, , PE21 9QS

Site Contact

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Powered By
The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

RSS MPN News

  • Contemporary Approach CALR Positive MPNs
  • 9 Tips to Reduce MPN Fatigue
  • Common Clinical Trial Acronyms and Abbreviations
  • Understanding the Phases of Clinical Trials
  • 4th Angel providing one-on-one support services for MPN Patients

MPN 2019 guidelines

MPN 2019 Guidelines, PV Reporter

Click on the image above for the New MPN Patient Guidelines! Very detailed, provided by NCCN.

Medical Dislaimer

Sign up for Our Newsletter!

Copyright · PV Reporter © 2021 · Site Design by David Wallace
error: