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New Pill-and-Shot combo aims to tame thick blood

NCT ID NCT07445893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.