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A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study

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Trial Profile

A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2025

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary) ; Anagrelide
  • Indications Essential thrombocythaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms SURPASS ET
  • Sponsors PharmaEssentia Corporation

Most Recent Events

  • 07 Jan 2025 According to a PharmaEssentia Corporation media release, Company plans to present detailed clinical trial results, including additional pharmacokinetics and biomarker data, at a later date. and submit these results to the FDA and other regulatory agencies to leverage these data to expand the existing P1101 product label and further expand the reach of P1101 to address this growing global unmet medical need.
  • 07 Jan 2025 Topline Results published in the PharmaEssentia Corporation Media Release
  • 06 Jan 2025 According to a PharmaEssentia Corporation media release, Primary endpoint (Durable clinical response)has been met.

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