Last updated 42 hours ago
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
250 patients around the world
Available in Brazil, United States
Ono Pharmaceutical Co., Ltd.
2Research sites
250Patients around the world
This study is for people with
Myeloproliferative syndromes
Polycythemia vera
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.Participants must be phlebotomy-dependent.Hct less than (<) 45% at study start.Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.Adequate organ function and electrolytes.
- Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.Participants who require phlebotomy at Hct levels <45%.Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.
Sites
Instituto Joinvilense de Hematologia e Oncologia (CEPEVILLE)
Recruiting
Meso Clinic Pesquisa Clinica
Recruiting
StudyINTREPID
SponsorOno Pharmaceutical Co., Ltd.
Study typeInterventional
Conditions
Polycythemia vera
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07429266
