A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia Vera
Completed · Phase 2
Conditions studied: Phlebotomy Dependent Polycythemia Vera
In brief
The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera.
Key facts
- Study ID
- NCT05143957
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 50
- Starts
- 2021-12-30
- Expected to finish
- 2026-06-02
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify 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.
- Participants 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 on cytoreductive therapy it must have been discontinued at least 3 months prior to Screening, with all associated AEs resolved. If the patient is currently on cytoreductive therapy they must be on a stable dose of hydroxyurea, recombinant or PEGylated interferon, or ruxolitinib for at least 3 months prior to Screening.
You may not qualify 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
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or non-metastatic prostate cancer that has been successfully treated
- Surgery requiring general anesthesia within 1 month prior to Screening
Where it is running
- O'Neal Comprehensive Cancer Center University of Alabama at Birmingham — Birmingham, Alabama, United States
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- John Theurer Cancer Center — Hackensack, New Jersey, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia
- Border Medical Oncology Research Unit — Albury, Australia
- McGill University Health Centre — Montreal, Quebec, Canada
- Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie, Klinika Hematoonkologii i Transplantacji Szpiku — Lublin, Poland
- Wojewódzki Szpital Specjalistyczny Sp. z o.o. — Słupsk, Poland
- MICS Centrum Medyczne Toruń — Torun, Poland
- Oxford University Hospitals NHS Foundation Trust — Oxford, England, United Kingdom
- University College London Hospitals NHS Foundation Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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