Myeloproliferative Neoplasms Clinical Trial

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

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.

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Full 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.

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Eligibility 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 and have either JAK2 V617F mutation or JAK2 exon 12 mutation.
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:

Hematocrit <45%,
WBC 4000/μL to 20,000/μL (inclusive), and
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 non-invasive non-melanomatous (e.g., squamous cell or basal cell carcinoma) skin cancer during screening unless adequately treated before randomization.
Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT05210790

Recruitment Status:

Recruiting

Sponsor:

Protagonist Therapeutics, Inc.

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There are 41 Locations for this study

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California Cancer Associates for Research and Excellence - Fresno
Fresno California, 93720, United States
Marin Cancer Care
Greenbrae California, 94904, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla California, 92037, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles California, 90095, United States
Stanford University
Palo Alto California, 94304, United States
University of Colorado - Aurora Cancer Center
Aurora Colorado, 80045, United States
BRCR Medical Center
Plantation Florida, 33322, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Northwest Oncology and Hematology
Rolling Meadows Illinois, 60008, United States
Orchard Healthcare Research Inc
Skokie Illinois, 60046, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda Maryland, 20817, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Cancer Care Specialists
Reno Nevada, 89511, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
Oregon Health and Science University (OHSU) Knight Cancer Institute
Portland Oregon, 97210, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
One Clinical Research
Nedlands Perth, , Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Medizinische Universitaet Graz
Graz , 8036, Austria
Klinikum Wels-Grieskirchen Gmb
Wels , 4600, Austria
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Fakultni nemocnice Brno
Brno , , Czechia
Fakultni nemocnice Olomouc
Olomouc , , Czechia
Vseobecna fakultni nemocnice v Praze
Praha , , Czechia
CHU Angers
Angers Cedex 09, , France
CHU Amiens Picardie - Hopital Sud
Amiens , , France
AP-HP Hopital Saint-Louis
Paris , 75010, France
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite , , France
Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)
Aachen , 52074, Germany
Universitaetsmedizin Greifswald
Greifswald , 17489, Germany
Queen Mary Hospital
Hong Kong , , Hong Kong
Semmelweis Egyetem
Budapest , 1085, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Hadassah Medical Center Ein Karem
Jerusalem , 12100, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center, Beilinson Hospital
Petach Tikva , 49100, Israel
Shamir Medical Center (Assaf Harofe)
Zerifin , 70300, Israel
Fondazione IRCCS Policlinico San Matteo
Pavia , , Italy
Fondazione Policlinico Univ. A . Gemelli IRCCS
Roma , 00168, Italy
Hospital Clinic Barcelona
Barcelona , 08036, Spain
Hospital Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital del Mar
Barcelona , 8003, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain
Hospital Quironsalud de Zaragoza
Zaragoza , , Spain
Pilgrim Hospital
Boston , PE21 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT05210790

Recruitment Status:

Recruiting

Sponsor:


Protagonist Therapeutics, Inc.

How clear is this clinincal trial information?

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