Clinical Trial

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Study acronym: SURPASS ET
Active, Not Recruiting Phase 3
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Summary
This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2020-02-23; most recent amendment 2026-07-20.
Status change: Recruiting → Active, Not Recruiting 2023-11-27
Status change: Not Yet Recruiting → Recruiting 2020-09-14
Trial Details
NCT Number NCT04285086
Lead Sponsor PharmaEssentia
Conditions Essential Thrombocythemia
Enrollment 174 participants
Start Date 2020-08-25
Primary Completion 2024-11-12 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-22