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A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera (VERIFY)

Primary Purpose

Polycythemia Vera

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Rusfertide
Sponsored by
Protagonist Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera focused on measuring Polycythemia Vera, PV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    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 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.

Sites / Locations

  • Infirmary Cancer CareRecruiting
  • City of Hope Medical Center, DuarteRecruiting
  • California Cancer Associates for Research and Excellence - FresnoRecruiting
  • Marin Cancer CareRecruiting
  • City of Hope Medical Center, LennerRecruiting
  • University of California, San Diego (UCSD) - Moores Cancer CenterRecruiting
  • University of California, Los Angeles (UCLA) - Medical CenterRecruiting
  • Stanford UniversityRecruiting
  • Pomona Valley Hospital Medical CenterRecruiting
  • University of California, San FranciscoRecruiting
  • City of Hope Medical Center, UplandRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • University of Colorado - Aurora Cancer CenterRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • BRCR Medical CenterRecruiting
  • BayCare Suncoast Medical Clinic - Hematology/OncologyRecruiting
  • Moffitt Cancer CenterRecruiting
  • Northwest Oncology and HematologyRecruiting
  • Orchard Healthcare Research IncRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kansas Cancer CenterRecruiting
  • Pontchartrain Cancer CenterRecruiting
  • Pontchartrain Cancer CenterRecruiting
  • American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)Recruiting
  • University of MichiganRecruiting
  • Cancer Care SpecialistsRecruiting
  • Memorial Sloan Kettering Cancer Center - BASKING RIDGERecruiting
  • Memorial Sloan Kettering Cancer Center - MONMOUTHRecruiting
  • Memorial Sloan Kettering Cancer Center - BERGENRecruiting
  • Montefiore Einstein Center for Cancer CareRecruiting
  • Montefiore Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer Center - COMMACKRecruiting
  • Memorial Sloan Kettering Cancer Center - WESTCHESTERRecruiting
  • Memorial Sloan Kettering Cancer Center - KOCHRecruiting
  • Ichan School of Medicine at Mount SinaiRecruiting
  • New York Presbyterian Hospital/Weill Cornell Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer Center - NASSAURecruiting
  • Duke University Medical CenterRecruiting
  • Gabrail Cancer CenterRecruiting
  • Oncology Associates of OregonRecruiting
  • Oregon Health and Science University (OHSU) Knight Cancer InstituteRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Texas Oncology San AntonioRecruiting
  • Community Cancer Trials of UtahRecruiting
  • HSHS St. Vincent HospitalRecruiting
  • HSHS St. Mary's HospitalRecruiting
  • One Clinical ResearchRecruiting
  • Royal Adelaide HospitalRecruiting
  • The Alfred HospitalRecruiting
  • Medizinische Universitaet GrazRecruiting
  • Kepler Universitaets Klinikum GmbHRecruiting
  • Krankenhaus der Elisabethinen LinzRecruiting
  • Wiener Gesundheitsverbund-Klinik Hietzing 5-Med.Recruiting
  • Klinikum Wels-Grieskirchen GmbRecruiting
  • Medizinische Universitaet WienRecruiting
  • ZNA StuivenbergRecruiting
  • University Hospital GentRecruiting
  • Campus GasthuisbergRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • Princess Margaret HospitalRecruiting
  • Centro de Estudios Clinicos SAGARecruiting
  • Biocenter Centro Clinico de InvestigacionRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice OlomoucRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • CHU AngersRecruiting
  • CHU PoitiersRecruiting
  • CHU Amiens Picardie - Hopital SudRecruiting
  • Centre Hospitalier d'ArgenteuilRecruiting
  • Centre Hospitalier de BeziersRecruiting
  • AP-HP Hopital Saint-LouisRecruiting
  • HCL Centre Hospitalier Lyon SudRecruiting
  • Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)Recruiting
  • Charite Universitaetsmedizin BerlinRecruiting
  • Gemeinschaftspraxis Haematologie - Onkologie - HauptstelleRecruiting
  • Universitaetsmedizin GreifswaldRecruiting
  • ONCOResearch Lerchenfeld GmbHRecruiting
  • InVo-Institut fuer Versorgungsforschung in der Onkologie GbRRecruiting
  • Universitaetsmedizin der Johannes Gutenberg - Universitaet MainzRecruiting
  • Queen Mary HospitalRecruiting
  • Semmelweis EgyetemRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Markhot Ferenc Oktatokorhaz es RendelointezetRecruiting
  • Rambam Health Care CampusRecruiting
  • Hadassah Medical Center Ein KaremRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Meir Medical CenterRecruiting
  • Rabin Medical Center - Davidoff Hematology CenterRecruiting
  • Sourasky Medical CenterRecruiting
  • Shamir Medical Center (Assaf Harofe)Recruiting
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadon"Recruiting
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecruiting
  • IRCCS Azienda Ospedaliero-Universtaria di BolognaRecruiting
  • UOC Ematologia - ASST Spedail Civill BresciaRecruiting
  • Azienda Ospedaliero - Universitaria CareggiRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Fondazione Policlinico Univ. A . Gemelli IRCCSRecruiting
  • AOU San Luigi Gonzaga OrbassanoRecruiting
  • AOU Citta della Salute e della Scienza di TorinoRecruiting
  • Azienda ASST-SETTELAGHI, Ospedale di Circolo e Fond. Macchi di Varese Ospedael VecchioRecruiting
  • Albert Schweitzer ZiekenhuisRecruiting
  • Erasmus MCRecruiting
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im.ks.B.MarkiewiczaRecruiting
  • MICS Centrum Medyczne BydgoszczRecruiting
  • Klinika Hematologii I Transplantologii - Uniwersyteckie Centrum KliniczneRecruiting
  • MICS Centrum Medyczne TorunRecruiting
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Oddział
  • Hospital de BragaRecruiting
  • CHULN - Hospital de Santa MariaRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Hospital Germans Trias i PujolRecruiting
  • Hospital del MarRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Hospital Quironsalud de ZaragozaRecruiting
  • Ankara Universitesi Tip Fakultesi Hematologi Bilim dali AnkaraRecruiting
  • Gazi University Medical FacultyRecruiting
  • Pamukkale University HospitalsRecruiting
  • Ege University Hospital Department of HematologyRecruiting
  • Karadeniz Technical University Medical Faculty Farabi HospitalRecruiting
  • Sanko Universitesi tip Fakultesi Ic Hastaliklari Anabilim DaliRecruiting
  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama HastanesiRecruiting
  • Marmara University Pendik Training & Research HospitalRecruiting
  • Erciyes Universitesi Tip Fakultesi Hastanesi, Dedeman HospitalRecruiting
  • Hillingdon HospitalRecruiting
  • Barnet HospitalRecruiting
  • Pilgrim HospitalRecruiting
  • Northwick Park HospitalRecruiting
  • The Royal London HospitalRecruiting
  • University College London HospitalRecruiting
  • Royal Free Hospital, Royal Free London NHSFTRecruiting
  • Churchill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rusfertide

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of subjects achieving a response who receive rusfertide compared to placebo.
Response is defined as absence of phlebotomy eligibility.

Secondary Outcome Measures

Comparison of mean number of phlebotomies between rusfertide and placebo.
Proportion of subjects with HCT values <45% for rusfertide and placebo.
Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
Comparison of mean change from baseline in total MFSAF total score.

Full Information

First Posted
January 14, 2022
Last Updated
October 5, 2023
Sponsor
Protagonist Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05210790
Brief Title
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Acronym
VERIFY
Official Title
A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protagonist Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycythemia Vera
Keywords
Polycythemia Vera, PV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind (Part 1a): Subjects will be randomized in a blinded fashion to 32 weeks of rusfertide or placebo added-on to each subject's ongoing treatment for polycythemia vera. Open-label (Part 1b + Part 2): Open-label treatment phase during which all subjects who complete Part 1a successfully will receive rusfertide for 124 weeks.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rusfertide
Arm Type
Experimental
Arm Description
Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rusfertide
Intervention Description
Experimental drug
Primary Outcome Measure Information:
Title
Proportion of subjects achieving a response who receive rusfertide compared to placebo.
Description
Response is defined as absence of phlebotomy eligibility.
Time Frame
Week 20 through Week 32
Secondary Outcome Measure Information:
Title
Comparison of mean number of phlebotomies between rusfertide and placebo.
Time Frame
Week 0 to Week 32
Title
Proportion of subjects with HCT values <45% for rusfertide and placebo.
Time Frame
Week 0 to Week 32
Title
Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
Time Frame
Week 32
Title
Comparison of mean change from baseline in total MFSAF total score.
Time Frame
Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
1-888-899-1543
Email
ptgxclintrials@ptgx-inc.com
Facility Information:
Facility Name
Infirmary Cancer Care
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope Medical Center, Duarte
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
California Cancer Associates for Research and Excellence - Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope Medical Center, Lenner
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Diego (UCSD) - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles (UCLA) - Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope Medical Center, Upland
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado - Aurora Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Name
BRCR Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Recruiting
Facility Name
BayCare Suncoast Medical Clinic - Hematology/Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Oncology and Hematology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Name
Orchard Healthcare Research Inc
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Pontchartrain Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Pontchartrain Cancer Center
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Specialists
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - BASKING RIDGE
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - MONMOUTH
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - BERGEN
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - COMMACK
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - WESTCHESTER
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - KOCH
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Ichan School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Presbyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - NASSAU
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Associates of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University (OHSU) Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Name
HSHS St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Individual Site Status
Recruiting
Facility Name
HSHS St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Individual Site Status
Recruiting
Facility Name
One Clinical Research
City
Nedlands
State/Province
Perth
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Kepler Universitaets Klinikum GmbH
City
Linz
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Wiener Gesundheitsverbund-Klinik Hietzing 5-Med.
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen Gmb
City
Wels
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
ZNA Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centro de Estudios Clinicos SAGA
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Name
Biocenter Centro Clinico de Investigacion
City
Concepción
ZIP/Postal Code
4070196
Country
Chile
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Prague
ZIP/Postal Code
128 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU Angers
City
Angers
State/Province
Cedex 09
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Poitiers
City
Poitiers
State/Province
Cedex
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Amiens Picardie - Hopital Sud
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier d'Argenteuil
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Beziers
City
Béziers
ZIP/Postal Code
34500
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
HCL Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Name
Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Individual Site Status
Recruiting
Facility Name
ONCOResearch Lerchenfeld GmbH
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Name
InVo-Institut fuer Versorgungsforschung in der Onkologie GbR
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Markhot Ferenc Oktatokorhaz es Rendelointezet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center Ein Karem
City
Jerusalem
ZIP/Postal Code
121000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center - Davidoff Hematology Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shamir Medical Center (Assaf Harofe)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadon"
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universtaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
UOC Ematologia - ASST Spedail Civill Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Univ. A . Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU San Luigi Gonzaga Orbassano
City
Torino
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda ASST-SETTELAGHI, Ospedale di Circolo e Fond. Macchi di Varese Ospedael Vecchio
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im.ks.B.Markiewicza
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Hematologii I Transplantologii - Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Torun
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Oddział
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
CHULN - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quironsalud de Zaragoza
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ankara Universitesi Tip Fakultesi Hematologi Bilim dali Ankara
City
Balkiraz
State/Province
Ankara
ZIP/Postal Code
06620
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Medical Faculty
City
Yenimahalle
State/Province
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Pamukkale University Hospitals
City
Pamukkale
State/Province
Denizli
ZIP/Postal Code
20160
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Hospital Department of Hematology
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Karadeniz Technical University Medical Faculty Farabi Hospital
City
Trabzon
State/Province
Ortahisar
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Sanko Universitesi tip Fakultesi Ic Hastaliklari Anabilim Dali
City
Gaziantep
State/Province
Sehitkamil
ZIP/Postal Code
27090
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
City
Gaziantep
ZIP/Postal Code
27410
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara University Pendik Training & Research Hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Erciyes Universitesi Tip Fakultesi Hastanesi, Dedeman Hospital
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hillingdon Hospital
City
Uxbridge
State/Province
Middlesex
ZIP/Postal Code
U38 3NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barnet Hospital
City
Barnet
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Pilgrim Hospital
City
Boston
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Northwick Park Hospital
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Free Hospital, Royal Free London NHSFT
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
36164011
Citation
Pemmaraju N, Kuykendall A, Kremyanskaya M, Ginzburg Y, Ritchie E, Gotlib J, Gerds A, Palmer J, Valone F, O'Connor P, Modi N, Gupta S, Hoffman R, Verstovsek S. MPN-469 Rusfertide (PTG-300) Treatment Interruption Reverses Hematological Gains and Upon Reinitiation, Restoration of Clinical Benefit Observed in Patients With Polycythemia Vera. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S338-S339. doi: 10.1016/S2152-2650(22)01462-8.
Results Reference
derived

Learn more about this trial

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

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