Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
Trial Parameters
Eligibility Fast-Check
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Brief 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 tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension 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 extension trials.
Eligibility Criteria
Inclusion Criteria: 1. Age \>= 18 years old and gender not limited when signing the informed consent form; 2. Diagnosed as PV according to WHO standards (2016 edition), and resistant/intolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2); 3. When screening, the peripheral blood primitive cells are 0%; 4. Meet any of the following criteria and achieve HCT\<= 45% before randomization/enrollment: 1)At least 2 venous bloodletting and/or apheresis treatments have been performed within 24 weeks prior to screening, with a minimum interval of 4 weeks between each treatment, and at least 1 treatment has occurred within 16 weeks prior to screening; 2)At least one venous bloodletting and/or apheresis treatment has been performed within the 16 weeks and HCT\>45% at the time of screening; 5.When screening, laboratory test indicators meet the following criteria: neutrophil count \>= 1.0 × 10 \^ 9/L, platelet count \>= 100 × 10 \^ 9/L and \<= 1000 × 10 \^ 9/L; ALT and AST\<=