Spots Global Cancer Trial Database for A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
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Trial Identification
Brief Title: A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Official Title: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera
Study ID: NCT05210790
Conditions
Study Description
Brief 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
Montefiore Medical Center, Bronx, New York, United States
New York Cancer and Blood Specialists, Bronx, 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
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
Wiener Gesundheitsverbund-Klinik Hietzing 5-Med., Vienna, , Austria
Klinikum Wels-Grieskirchen Gmb, Wels, , Austria
Medizinische Universitaet Wien, Wien, , Austria
ZNA Stuivenberg, Antwerp, , Belgium
University Hospital Gent, Gent, , 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, Montréal, Quebec, Canada
Centro Medico Inmunocel, Las Condes, Santiago, Chile
Centro de Estudios Clinicos SAGA, Providencia, Santiago, 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, Petach Tikva, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
Shamir Medical Center (Assaf Harofe), Zerifin, , 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, Firenze, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Ematologia (Padiglione Marcora),, Milano, , 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, Gdańsk, , Poland
Promed P.Lach R.Glowacki Spolka Jawna, Krakow, , Poland
Wojewodzkie Wielospecjalistyczne Centrum, Onkologii i Traumatologii im. M Kopernika w Lodzi, Lodz, , Poland
MICS Centrum Medyczne Torun, Toruń, , Poland
MTZ Clinical Research Powered by Pratia, Warszawa, , Poland
Centrum Medyczne Melita Medical, Wrocław, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Oddział, Łódź, , Poland
Conde Hospital Garcia de Orta, Almada, , Portugal
Hospital de Braga, Braga, , Portugal
CHULN - Hospital de Santa Maria, Lisboa, , 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
Gazi University Medical Faculty, Yenimahalle, Ankara, Turkey
Pamukkale University Hospitals, Pamukkale, Denizli, Turkey
Ege University Hospital Department of Hematology, Bornova, Izmir, Turkey
Karadeniz Technical University Medical Faculty Farabi Hospital, Trabzon, Ortahisar, Turkey
Sanko Universitesi tip Fakultesi Ic Hastaliklari Anabilim Dali, Gaziantep, Sehitkamil, Turkey
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi, Gaziantep, , Turkey
Marmara University Pendik Training & Research Hospital, Istanbul, , Turkey
Erciyes Universitesi Tip Fakultesi Hastanesi, Dedeman Hospital, Kayseri, , Turkey
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
Contact Details
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