A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV
ConditionPolycythemia Vera (PV)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuan Minghui
About this trial
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
Eligibility criteria
Qualifiers
Aged ≥18 years
Diagnosis of polycythemia vera (PV) according to the 2022 International Consensus Classification (ICC) criteria;
No current plan for stem cell transplantation;
Life expectancy >24 weeks;
Disqualifiers
Any significant clinical or laboratory abnormality considered by the investigator to affect safety assessment, such as:a. Uncontrolled diabetes (>250 mg/dL or >13.9 mmol/L);b. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg);c. Peripheral neuropathy (Grade ≥2 according to NCI-CTCAE V5.0).
History of congestive heart failure (Grade ≥3 according to NCI-CTCAE V5.0), uncontrolled or unstable angina pectoris or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening.
Patients who have undergone major surgery within 4 weeks prior to screening and have not fully recovered.
Patients who have received PEG-IFN-α-2a or have a history of ³²P therapy within 5 weeks prior to screening.
Trial design
Treatments tested in this trial
- Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Duan Minghui
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov