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A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of sapablursen (ISIS 702843-CS4) Administered to Patients with Phlebotomy Dependent Polycythemia Vera (PD-PV)
EU CTIS ID: 2024-512482-14-00
What this study is testing
Evaluate the efficacy of sapablursen to reduce the frequency of phlebotomy throughout the last 20 weeks of the Treatment Period
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
- Participant must be phlebotomy dependent
- Patients do not need to be on cytoreductive therapy and do not need to have been previously treated with cytoreductive therapy. If the patient was previously treated with the cytoreductive therapy it must have been discontinued at least 3 months prior to Screening. If patients are currently on cytoreductive therapy they must be on a stable dose for at least 3 months prior to Screening.
You likely can't join if
- Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
- Moderate to severe splenic pain or spleen-related organ obstruction
- Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP)
- Known primary or secondary immunodeficiency
- Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
- Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection
See the full eligibility criteria
- Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
- Participant must be phlebotomy dependent
- Patients do not need to be on cytoreductive therapy and do not need to have been previously treated with cytoreductive therapy. If the patient was previously treated with the cytoreductive therapy it must have been discontinued at least 3 months prior to Screening. If patients are currently on cytoreductive therapy they must be on a stable dose for at least 3 months prior to Screening.
- Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
- Moderate to severe splenic pain or spleen-related organ obstruction
- Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP)
- Known primary or secondary immunodeficiency
- Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
- Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or nonmetastatic prostate cancer that has been successfully treated
- Surgery requiring general anesthesia within 1 month prior to Screening
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- United Kingdom
- Canada
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; United Kingdom; Canada. 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 EU CTIS; the study team decides eligibility.