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

NCT07232290 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • Polycythemia Vera (PV)

Interventions

DRUG

Flonoltinib 75mg

Flonoltinib Maleate Tablet 75mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.

DRUG

Flonoltinib 100mg

Flonoltinib Maleate Tablet 100mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.

DRUG

Flonoltinib 125mg

Flonoltinib Maleate Tablet 125mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.

DRUG

Extended Phase Dose Group

Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lei Zhang, Doctor · Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

  • Ting Niu, Doctor · West China Hospital

  • Wei Yang, Doctor · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2027-07-30
Completion
2028-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232290 on ClinicalTrials.gov