Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Angela Fleischman (uci)

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, & Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.

Official Title

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Keywords

Polycythemia Vera, Sapablursen

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
  2. Participants must be phlebotomy-dependent.
  3. Hct less than (<) 45% at study start.
  4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.
  5. Adequate organ function and electrolytes.

You CAN'T join if...

  1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.
  2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.
  3. Participants who require phlebotomy at Hct levels <45%.
  4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.
  5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.

Locations

  • UC Irvine Health - Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 93868 United States
  • The Cancer and Hematology Centers accepting new patients
    Grand Rapids Michigan 49503 United States

Lead Scientist at University of California Health

  • Angela Fleischman (uci)
    Associate Professor, Medicine, School of Medicine. Authored (or co-authored) 68 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ono Pharmaceutical Co., Ltd.
ID
NCT07429266
Phase
Phase 3 Polycythemia Vera Research Study
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated