Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05210790
Study type Interventional
Source Protagonist Therapeutics, Inc.
Contact Study Director
Phone 1-888-899-1543
Status Recruiting
Phase Phase 3
Start date April 1, 2022
Completion date June 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05558696 - A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004) Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Completed NCT02912884 - Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
Recruiting NCT02897297 - Myeloproliferative Neoplastic Diseases Observatory From Brest
Completed NCT01949805 - Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera Phase 3
Completed NCT00666549 - Research Tissue Bank
Completed NCT00241241 - Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera Phase 2
Completed NCT00052520 - Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Phase 1/Phase 2
Active, not recruiting NCT05485948 - A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU Phase 2
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Completed NCT01243944 - Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) Phase 3
Recruiting NCT05481151 - A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV Phase 3
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Recruiting NCT04116502 - MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera Phase 3
Completed NCT01901432 - A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Phase 1/Phase 2
Recruiting NCT04262141 - IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) Phase 2
Not yet recruiting NCT05566535 - Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice
Active, not recruiting NCT04057040 - Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE) Phase 2
Completed NCT03907436 - The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase N/A
Completed NCT01981850 - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Phase 2