Polycythemia Vera (PV)NCT07445893
A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV
A study testing Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b in people with Polycythemia Vera (PV), run by Duan Minghui at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera (PV)
- What is being tested?
- Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2026to 30 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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;
Show all 14Show fewer
- ECOG performance status 0-2;
- Able to swallow tablets;
- Patients without prior pegylated interferon or JAK inhibitor treatment; patients previously treated with hydroxyurea or therapeutic phlebotomy are eligible; patients who discontinued interferon for ≥6 months due to causes other than resistance or intolerance can be enrolled；
- 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.
Who cannot join
- 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.
- Patients diagnosed with primary immunodeficiency syndrome (e.g., X-linked agammaglobulinemia and common variable immunodeficiency).
- Patients with arrhythmic disorders requiring treatment at screening (except digoxin).
Show all 19Show fewer
- Patients with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening.
- Patients with active pulmonary infection indicated by chest CT examination at screening.
- Patients previously diagnosed with active tuberculosis infection, or subjects judged as suspected active tuberculosis infection by investigator at screening.
- Patients who have undergone splenectomy or have received splenic radiation therapy within 48 weeks prior to screening.
- Patients who are HIV positive, have active hepatitis B virus infection (HBsAg positive and HBV-DNA positive or above the normal reference range), or are anti-HCV antibody positive with HCV-RNA positive at screening.
- Patients with epilepsy or those using psychiatric or sedative medications at screening (except for Estazolam tablets).
- Female patients who are planning to become pregnant, are pregnant, or are breastfeeding, and patients who are unable to use effective contraception throughout the study period; male patients who do not use condoms during the administration period and for 2 days (approximately 5 half-lives) after the last dose.
- Patients with a history of malignancy within the past 5 years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Presence of other severe diseases that, in the investigator's opinion, may affect patient safety or compliance.
- Patients with suspected allergy to Gecacitinib Hydrochloride, interferon, or similar drugs.
- Patients with active alcohol or drug addiction that would interfere with their ability to comply with study requirements.
- Patients who have participated in another investigational new drug or medical device study and have received study drug or used study device within 12 weeks prior to screening.
- Patients who have used any immunomodulators, any immunosuppressants, ≥10 mg/day prednisone or equivalent corticosteroids, or are within 6 half-lives of such medications within 2 weeks prior to enrollment, whichever is longer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
About this study
Official title: A Clinical Study of Gecacitinib Hydrochloride Tablets Combined With Pegylated Interferon as First-line Treatment in Patients With Polycythemia Vera (PV)
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
- Conditions
- Polycythemia Vera (PV)
- Being tested
- Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b
- Keywords
- PV, Gecacitinib, Pegylated Interferon, JAKi
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2bDrug
Gecacitinib Hydrochloride Tablets: 100 mg twice daily (BID), orally, on an empty stomach.
Pegylated interferon alfa-2b: 90 μg once weekly, subcutaneous injection in the abdomen or thigh.
| Study group | Role | What they receive |
|---|---|---|
| Gecacitinib，Pegylated interferon alfa-2b | Experimental | Drug：Gecacitinib Hydrochloride Tablets，Pegylated interferon alfa-2b Receives: Drug: Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic remission rate at Week 24
Simultaneous achievement of HCT <45%, WBC <10×10⁹/L, and PLT ≤400×10⁹/L
Measured: Week 24
Secondary outcomes (6)
HCT remission rate
Proportion of patients achieving HCT <45% at 24 weeks
Measured: week 24
Time to HCT remission
Time from treatment initiation to HCT remission
Measured: Up to 24 weeks
Duration of HCT remission
Interval from first achievement of HCT remission to reappearance of HCT ≥45%
Measured: Through study completion, an average of 2 year
Proportion of patients achieving spleen reduction at 24 weeks
≥10% shortening of the longest spleen diameter by palpation or normalization of spleen size
Measured: Week 4, Week 12, Week 24
Proportion of patients achieving symptom improvement at 24 weeks
≥50% reduction in total symptom score on the MPN Symptom Assessment Form. The MPN-SAF-TSS is used to assess the symptom burden of patients with myeloproliferative neoplasms. The questionnaire also reflects the quality of life of patients to a certain extent. During the diagnosis and treatment process, the MPN-10 questionnaire includes 10 sub symptoms (fatigue, early satiety, abdominal discomfort, poor activity, lack of concentration, night sweats, skin itching, bone pain, fever, and weight loss). Each item is graded from 0 (none) to 10 (heaviest), with a total score of 0-100 points. The higher the total score, the heavier the symptom burden.
Measured: Week 4, Week 12, Week 24
Percentage reduction in JAK2 mutation burden after 24 weeks of treatment
Measured: Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia Vera (PV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duan Minghui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duan Minghui, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445893
- Sponsor's protocol ID
- I-26PJ0389
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided