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ACTIVE NOT RECRUITING
NCT05210790
PHASE3

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Sponsor: Protagonist Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

293

Start Date

2022-04-01

Completion Date

2027-06

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DRUG

Placebo

Placebo

DRUG

Rusfertide

Experimental drug

Locations (184)

Infirmary Cancer Care

Mobile, Alabama, United States

Palo Verde Hematology-Oncology

Glendale, Arizona, United States

City of Hope Medical Center, Duarte

Duarte, California, United States

California Cancer Associates for Research and Excellence - Fresno

Fresno, California, United States

Marin Cancer Care

Greenbrae, California, United States

City of Hope Medical Center, Lenner

Irvine, California, United States

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

La Jolla, California, United States

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

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

Sharp Memorial Hospital

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

City of Hope Medical Center, Upland

Upland, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

University of Colorado - Aurora Cancer Center

Aurora, Colorado, United States

Rocky Mountain Cancer Centers - Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, United States

BRCR Medical Center

Plantation, Florida, United States

BayCare Suncoast Medical Clinic - Hematology/Oncology

St. Petersburg, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Northwest Oncology and Hematology

Rolling Meadows, Illinois, United States

Orchard Healthcare Research Inc

Skokie, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Mission Cancer & Blood

Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Pontchartrain Cancer Center

Covington, Louisiana, United States

Pontchartrain Cancer Center

Hammond, Louisiana, United States

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

Bethesda, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Cancer Care Specialists

Reno, Nevada, United States

Memorial Sloan Kettering Cancer Center - BASKING RIDGE

Basking Ridge, New Jersey, United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Memorial Sloan Kettering Cancer Center - MONMOUTH

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center - BERGEN

Montvale, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

New York Cancer and Blood Specialists

Babylon, New York, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center - COMMACK

Commack, New York, United States

Memorial Sloan Kettering Cancer Center - WESTCHESTER

Harrison, New York, United States

New York Cancer and Blood Specialists

New Hyde Park, New York, United States

Memorial Sloan Kettering Cancer Center - KOCH

New York, New York, United States

New York Cancer and Blood Specialists

New York, New York, United States

Ichan School of Medicine at Mount Sinai

New York, New York, United States

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

New York Cancer and Blood Specialists

Patchogue, New York, United States

New York Cancer and Blood Specialists

Port Jefferson Station, New York, United States

New York Cancer and Blood Specialists

Riverhead, New York, United States

Wilmot Cancer Institute, University of Rochester

Rochester, New York, United States

Montefiore Einstein Center for Cancer Care

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

New York Cancer and Blood Specialists

The Bronx, New York, United States

Memorial Sloan Kettering Cancer Center - NASSAU

Uniondale, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

TriHealth Cancer Institute - Good Samaritan Hospital

Cincinnati, Ohio, United States

Good Samaritan Infusion Center - Kenwood

Cincinnati, Ohio, United States

Good Samaritan Infusion Center - Thomas

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology San Antonio

San Antonio, Texas, United States

Community Cancer Trials of Utah

Ogden, Utah, United States

University of Washington - Fred Hutchinson Cancer Center

Seattle, Washington, United States

HSHS St. Vincent Hospital

Green Bay, Wisconsin, United States

HSHS St. Mary's Hospital

Green Bay, Wisconsin, United States

One Clinical Research

Nedlands, Perth, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Kepler Universitaets Klinikum GmbH

Linz, Austria

Krankenhaus der Elisabethinen Linz

Linz, Austria

Medizinische Universitaet Wien

Vienna, Austria

Wiener Gesundheitsverbund-Klinik Hietzing 5-Med.

Vienna, Austria

Klinikum Wels-Grieskirchen Gmb

Wels, Austria

ZNA Stuivenberg

Antwerp, Belgium

University Hospital Gent

Ghent, Belgium

Campus Gasthuisberg

Leuven, Belgium

The University of Alberta - Edmonton

Edmonton, Alberta, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centro Medico Inmunocel

Las Condes, Santiago Metropolitan, Chile

Centro de Estudios Clinicos SAGA

Providencia, Santiago Metropolitan, Chile

Biocenter Centro Clinico de Investigacion

Concepción, Chile

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

CHU Angers

Angers, Cedex 09, France

AP-HP Hospital Necker-Enfants Malades

Paris, Cedex 15, France

CHU Poitiers

Poitiers, Cedex, France

CHU Amiens Picardie - Hopital Sud

Amiens, France

Centre Hospitalier d'Argenteuil

Argenteuil, France

Centre Hospitalier de Beziers

Béziers, France

AP-HP Hopital Saint-Louis

Paris, France

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, France

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

Aachen, Germany

Charite Universitaetsmedizin Berlin

Berlin, Germany

Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

Dresden, Germany

Universitaetsmedizin Greifswald

Greifswald, Germany

ONCOResearch Lerchenfeld GmbH

Hamburg, Germany

InVo-Institut fuer Versorgungsforschung in der Onkologie GbR

Koblenz, Germany

Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

Mainz, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Semmelweis Egyetem

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Hungary

Rambam Health Care Campus

Haifa, Israel

Hadassah Medical Center Ein Karem

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center - Davidoff Hematology Center

Petah Tikva, Israel

Sourasky Medical Center

Tel Aviv, Israel

Shamir Medical Center (Assaf Harofe)

Ẕerifin, Israel

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadon"

Meldola, Forli-Cesena, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Italy

IRCCS Azienda Ospedaliero-Universtaria di Bologna

Bologna, Italy

UOC Ematologia - ASST Spedail Civill Brescia

Brescia, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Ematologia (Padiglione Marcora),

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

UOC Ematologia e Centro Trapianti AST Pesaro Urbino, Stabilimento Muraglia

Pesaro, Italy

Fondazione Policlinico Univ. A . Gemelli IRCCS

Roma, Italy

AOU San Luigi Gonzaga Orbassano

Torino, Italy

AOU Citta della Salute e della Scienza di Torino

Torino, Italy

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

Varese, Italy

Centro de Estudios de Investigacion SIYODE

Madero, Mexico

SUPERARE Centro de Infusion S.A. de C.V.

Mexico City, Mexico

Boca Clinical Trials Mexico S.C. - Ciudad de Mexico

Mexico City, Mexico

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Erasmus MC

Rotterdam, Netherlands

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

Brzozów, Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Klinika Hematologii I Transplantologii - Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Promed P.Lach R.Glowacki Spolka Jawna

Krakow, Poland

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

Lodz, Poland

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

Lodz, Poland

MICS Centrum Medyczne Torun

Torun, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Centrum Medyczne Melita Medical

Wroclaw, Poland

Conde Hospital Garcia de Orta

Almada, Portugal

Hospital de Braga

Braga, Portugal

CHULN - Hospital de Santa Maria

Lisbon, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Germans Trias i Pujol

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Hospital Quironsalud de Zaragoza

Zaragoza, Spain

Ankara Universitesi Tip Fakultesi Hematologi Bilim dali Ankara

Balkiraz, Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Yenimahalle, Ankara, Turkey (Türkiye)

Pamukkale University Hospitals

Pamukkale, Denizli, Turkey (Türkiye)

Ege University Hospital Department of Hematology

Bornova, İzmir, Turkey (Türkiye)

Karadeniz Technical University Medical Faculty Farabi Hospital

Trabzon, Ortahisar, Turkey (Türkiye)

Sanko Universitesi tip Fakultesi Ic Hastaliklari Anabilim Dali

Gaziantep, Sehitkamil, Turkey (Türkiye)

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, Turkey (Türkiye)

Marmara University Pendik Training & Research Hospital

Istanbul, Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi Hastanesi, Dedeman Hospital

Kayseri, Turkey (Türkiye)

Hillingdon Hospital

Uxbridge, Middlesex, United Kingdom

Barnet Hospital

Barnet, United Kingdom

Pilgrim Hospital

Boston, United Kingdom

Northwick Park Hospital

Harrow, United Kingdom

The Royal London Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

Royal Free Hospital, Royal Free London NHSFT

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom