A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV (NCT07445893) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV
30 participantsStarted 2026-02-24
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of Gecacitinib in combination with pegylated interferon for the treatment of polycythemia vera (PV).The main question it aims to answer is:
Can PV patients achieve hematological remission after receiving the combination therapy?
Participants will:
Receive combination treatment with Gecacitinib Hydrochloride Tablets and pegylated interferon for 24 weeks Visit the hospital regularly for examinations and follow-up assessments
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Aged ≥18 years
* Diagnosis of polycythemia vera (PV) according to the 2022 International Consensus Classification (ICC) criteria;
* Presence of at least one of the following disease manifestations, defined as:
a. Peripheral hematological abnormality: HCT ≥45% and/or PLT \>400×10⁹/L and/or WBC ≥10×10⁹/L in the absence of phlebotomy; b. Presence of weight loss \>10% over the past 6 months, night sweats, pruritus, or unexplained fever (\>37.5°C); c. Progressive splenomegaly (previous splenomegaly with an increase \>5 cm from baseline or newly developed splenomegaly); d. History of prior thrombotic or hemorrhagic events;
* No current plan for stem cell transplantation;
* Life expectancy \>24 weeks;
* ECOG performance status 0-2;
* Able to swallow tablets;
* No prior treatment with interferon or JAK inhibitors (patients who have received hydroxyurea or phlebotomy are eligible);
* No receipt of growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks prior to screening, with platelet count ≥100×10⁹/L and ANC ≥1.5×10⁹/L;
* Adequate major organ function, defined asALT and AST ≤2.5 × ULN;DBIL and TBIL ≤2.0 × ULN;Serum creatinine ≤1.5 × ULN;
* Peripheral blood blasts 0%;
* Voluntary signed informed consent in accordance with ethics committee requirements;
* Able to comply with study and follow-up procedures.
Exclusion Criteria:
* Any significant clinical or laboratory abnormality considered by the investigator to aff…