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INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)

Study acronym: INTREPID
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 10 → 17 locations Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 2 of 7 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Minor Study sites: 8 to 10v7
  3. Minor Study sites: 6 to 8v6
  4. Minor Study sites: 5 to 6v5
  5. Minor Trial sites expanded: 1 → 5 locationsv4
  6. Minor Start date changed from estimate of Jun 2026 to May 25, 2026 Study title expanded, about 1 wordv3 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. Notable Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  8. Notable Changed Sponsor changed: Ono Pharmaceutical Co. Ltd to Ono Pharmaceutical Co., Ltd.
  9. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07429266
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Collaborators: Deciphera Pharmaceuticals, LLC
Conditions Polycythemia Vera
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov