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NCT07429266
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Conditions: Polycythemia Vera
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 250
Sponsor: Ono Pharmaceutical Co., Ltd.
Location: UC Irvine Health - Chao Family Comprehensive Cancer Center Orange California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
2. Participants must be phlebotomy-dependent.
3. Hct less than (\
Source: ClinicalTrials.gov (NCT07429266). StuddyBuddy aggregates publicly available trial information.
