Phase IIa Study of Flonoltinib Maleate Tablets in Adults with Polycythemia Vera Resistant or Intolerant to Hydroxyurea or Interferon

What this Trial Is About

Researchers are conducting a Phase IIa clinical trial to study Flonoltinib Maleate Tablets in patients with polycythemia vera PV who are resistant or intolerant to hydroxyurea or interferon treatments. Polycythemia vera is a bone marrow disorder with a goal of preventing thrombosis and disease progression. This trial involves an open, randomized, parallel-controlled, multicenter design to evaluate safety, effectiveness, and how the body processes the drug. The trial has two stages a dose exploration phase with three dose groups 75mg, 100mg, and 125mg where each group includes three subjects for 8 weeks of daily oral treatment on an empty stomach and a dose extension phase selecting 2-3 doses based on safety, efficacy, and pharmacokinetic data from the first stage. Participants receive Flonoltinib once daily, with doses adjusted as needed during the extension. Participants will undergo regular assessments including blood tests to control hematocrit levels, symptom scoring using the MPN-SAF TSS scale, and monitoring for thrombosis or bleeding. The primary outcome is the proportion of subjects achieving hematocrit control at week 28. Secondary measures include hematological remission, symptom changes, gene mutation burden, and safety evaluations. The study lasts at least 28 weeks with follow-up visits to monitor results and drug effects.

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