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Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

Trial Profile

Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Ruxolitinib (Primary)
  • Indications Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms RESPONSE
  • Sponsors Incyte Corporation; Novartis
  • Most Recent Events

    • 12 Dec 2023 Results of pooled analysis of RESPONSE and RESPONSE 2 describing patient benefit of ruxolitinib in patients with PV with or without splenomegaly,presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 13 Dec 2022 Results of a study assessing changes of JAK2V617F variant allele fraction in PV and ET patients who were long-term treated with ruxolitinib from tow clinical studies: REPSONSE-1 and RESPONSE-2 presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 06 Nov 2019 Results demonstrating benefits and long term clinical efficacy of the ruxolitinib treatment in patients who did and did not achieve the protocol defined HCT control, released in 61st Annual Meeting and Exposition of the American Society of Hematology
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