Clinical Trial

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

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-13.
Status change: Active, Not Recruiting → Recruiting 2026-03-02
Trial Details
NCT Number NCT07232290
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions Polycythemia Vera (PV)
Enrollment 60 participants
Start Date 2025-09-23
Primary Completion 2027-07-30 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-14