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)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion 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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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