New Pill-and-Shot combo aims to tame thick blood
NCT ID NCT07445893
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new pill (gecacitinib) plus a weekly injection (pegylated interferon) can help people with polycythemia vera, a condition where the body makes too many red blood cells. The goal is to bring blood counts back to normal and ease symptoms. Thirty adults will take the combination for 24 weeks and be closely monitored.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gecacitinib hydrochloride tablets and pegylated interferon alfa-2b
- What this could lead to
- If successful, this combination could offer a new first-line treatment option to control blood cell counts and reduce symptoms in polycythemia vera patients.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to everyone. The combination may cause side effects like flu-like symptoms or blood cell changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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; * 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. Exclusion Criteria: * 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). * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Polycythemia vera (PV) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking Union Medical College Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted drug outperform standard care for rare blood cancers?
- New drug ZE74-0282 targets rare blood cancers in early trial
- New hope for rare blood cancers: first human trial of PRT12396 begins
- Massive new study aims to unlock secrets of rare blood cancers
- Blood thickens during exercise in rare disorder, study aims to find why
- Can a $10 arthritis pill tame rare blood cancers?