BridgeMD
Tests treatment safety and results for Polycythemia Vera
Official title INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
ClinicalTrials.gov ID: NCT07429266
What this study is testing
What is Sapablursen?
Sapablursen is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for polycythemia vera.
Also referred to as ONO-0530, ISIS 702843.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Time commitment: about 156 weeks
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Bethesda, Maryland, United States
- The Bronx, New York, United States
- Canton, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 156 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Plantation, Florida, United States; Tamarac, Florida, United States; Bethesda, Maryland, United States; The Bronx, New York, United States; Canton, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.