Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
NCT ID: NCT04057040
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2019-10-01
2024-06-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit
NCT04767802
Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
NCT01420783
Ruxolitinib in Thrombocythemia and Polycythemia Vera
NCT04644211
A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera
NCT01901432
Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
NCT02292446
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
28 week open-label dose escalation phase in which each subject's dose of PTG-300 is titrated to achieve a hematocrit \<45%.
Part 2:
12-week blinded randomized withdrawal phase. Subjects are randomized 1:1 to continue PTG-300 or to receive placebo.
Part 3:
Up to 3 year open label extension.
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose finding PTG-300 (Part 1); PTG-300 (Part 2); Open label extension PTG-300 (Part 3)
PTG-300
Active
Dose finding PTG-300 (Part 1); Placebo (Part 2); Open label extension PTG-300 (Part 3)
PTG-300
Active
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PTG-300
Active
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera.
3. Records of all phlebotomies performed for at least 28 weeks (preferably up to 52 weeks) before dosing are available.
4. Subjects who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy.
5. Subjects receiving cytoreductive therapy with hydroxyurea, interferon, or ruxolitinib must have received cytoreductive therapy for at least 24 weeks and be on a stable dose or have a decreasing dose (Medical Monitor approval required) for at least 8 weeks before dosing and with no planned change in dose.
Exclusion Criteria
2. Meets the criteria for post-PCV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
3. Known primary or secondary immunodeficiency.
4. Any surgical procedure requiring general anesthesia within 1 month prior to screening or planned elective surgery during the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Protagonist Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic - Mayo Clinic Hospital
Phoenix, Arizona, United States
Marin Cancer Care
Greenbrae, California, United States
Stanford University
Palo Alto, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Kansas
Westwood, Kansas, United States
Pontchartrain Cancer Care
Covington, Louisiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Mount Sinai
New York, New York, United States
New York Presbyterian Hospital - Weill Cornell Medical Center
New York, New York, United States
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Sahyadri Super Specialty Hospital
Pune, Maharashtra, India
All India Institute of Medical Sciences
Rishikesh, Uttarakhand, India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kremyanskaya M, Kuykendall AT, Pemmaraju N, Ritchie EK, Gotlib J, Gerds A, Palmer J, Pettit K, Nath UK, Yacoub A, Molina A, Saks SR, Modi NB, Valone FH, Khanna S, Gupta S, Verstovsek S, Ginzburg YZ, Hoffman R; REVIVE Trial Investigators. Rusfertide, a Hepcidin Mimetic, for Control of Erythrocytosis in Polycythemia Vera. N Engl J Med. 2024 Feb 22;390(8):723-735. doi: 10.1056/NEJMoa2308809.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PTG-300-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.