Actively Recruiting
A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-05-08
250
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
O
Ono Pharmaceutical Co., Ltd.
Lead Sponsor
D
Deciphera Pharmaceuticals, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
- Participants must be phlebotomy-dependent.
- Hematocrit (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.
You will not qualify if you...
- Prior treatment of PV with 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 less than 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Regis Clinical Research LLC.
Miami, Florida, United States, 33126
Actively Recruiting
Research Team
C
Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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