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A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Sponsor: Protagonist Therapeutics, Inc.
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
Conditions
Interventions
Placebo
Placebo
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