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Phase IIa Study of Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints revised (5)
    • Study description revised
    • Study title revised
    • Eligibility criteria shortened, about 3 words
    v3
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon. The study divided into two stages: dose exploration stage: three dose groups are set, with three subjects in each group, totally nine subjects in each group; Dose expansion stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose expansion stage.
Trial Details
NCT Number NCT07232290
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions
(from sponsor)		 Polycythemia Vera (PV)
Related terms Polycythemia Vera
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov