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New drug could reduce Blood-Letting for polycythemia vera patients

NCT ID NCT07429266

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 8 times

Summary

This phase 3 trial tests whether adding the drug sapablursen to standard treatment helps people with polycythemia vera, a blood disorder causing too many red blood cells. About 250 participants who currently need regular blood removal (phlebotomy) will receive either sapablursen or a placebo for up to 156 weeks. The main goal is to see if the drug reduces the need for phlebotomy and improves fatigue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sapablursen (a drug injected under the skin)
What this could lead to
If it works, this could offer a new treatment option to help control polycythemia vera and reduce the need for regular blood removal (phlebotomy).
What could go wrong
This is still an experimental drug, and its safety and effectiveness are not yet proven. Even if successful, it would manage the disease rather than cure it, and long-term risks are unknown.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV. 2. Participants must be phlebotomy-dependent. 3. Hct less than (\<) 45% at study start. 4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start. 5. Adequate organ function and electrolytes. Exclusion Criteria: 1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics. 2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization. 3. Participants who require phlebotomy at Hct levels \<45%. 4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment. 5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polycythemia vera

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Central Georgia Cancer Care

    RECRUITING

    Macon, Georgia, 31210, United States

  • Florida Clinical Trials Group

    RECRUITING

    Plantation, Florida, 33322, United States

  • Florida Clinical Trials Group

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Gabrail Cancer Center Research

    RECRUITING

    Canton, Ohio, 44718, United States

  • Japanese Red Cross Nagasaki Genbaku Hospital

    RECRUITING

    Nagasaki, 852-8511, Japan

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Perth Blood Institute

    RECRUITING

    West Perth, Western Australia, 6005, Australia

  • Regis Clinical Research LLC.

    RECRUITING

    Miami, Florida, 33126, United States

  • The Cancer and Hematology Centers

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

    Contact Email: •••••@•••••

  • The Center for Cancer & Blood Disorders

    RECRUITING

    Bethesda, Maryland, 20817, United States

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