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Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Study acronym: GIV-IN-PV
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 25, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 82 to 90v13
  2. Study sites: 76 to 82v12
  3. Eligibility criteria expanded, about 142 words Study description expanded, about 195 words · Study sites revised (76) · Collaborators expanded, about 3 wordsv11 Show 3 more changesShow less
    • Study description expanded, about 195 words
    • Study sites revised (76)
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv10
  5. Study sites: 38 to 76v9
Show 7 earlier versionsHide 7 earlier versions
  1. Interventions: Givinostat Hydrochloride (Drug), Hydroxy Urea (Drug) to Givinostat (Drug), Hydroxyurea (Drug) Eligibility criteria revisedv8 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 37 to 38v7
  3. Study sites: 27 to 37v6
  4. Study sites: 5 to 27v5
  5. Study sites: 1 to 5 Start date changed from estimate of Mar 2024 to Mar 26, 2024v4 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2024 to Mar 26, 2024
  6. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2024 to Mar 2024v3 Show 1 more changeShow less
    • Start date: Feb 2024 to Mar 2024
  7. Start date: Dec 2023 to Feb 2024v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.
Trial Details
NCT Number NCT06093672
Lead Sponsor Italfarmaco
Collaborators: PPD Development, LP
Conditions Polycythemia Vera
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov