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New shot aims to boost platelets in ITP patients

NCT ID NCT06880081

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called PN20 in 12 adults with primary immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, raising bleeding risk. Participants receive a single injection of PN20, which is designed to stimulate platelet production. The main goal is to check safety and see if platelet counts improve within 28 days.

What this could mean

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

Active substance
PN20 (thrombopoietin receptor agonist)
What this could lead to
If successful, this could point toward a new treatment option to raise platelet counts and reduce bleeding risk in people with ITP.
What could go wrong
This is a very early, small Phase 1b trial with only 12 participants, so results may not apply broadly. The main goal is safety, not proof of effectiveness, and side effects are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Started

Mar 2025

Expected to finish

Apr 2026

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 to 65 years

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.

Key Inclusion Criteria: 1. Aged between 18 and 65 years (inclusive), male or female; 2. Diagnosed with primary immune thrombocytopenia (ITP) and have a disease course of more than 6 months; 3. Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP (such as glucocorticoids, immunoglobulin) and have failed to respond or relapsed after treatment; 4. During screening period, the mean of two platelet counts must be \< 30 × 10\^9/L, with none \>35 × 10\^9/L; 5. Fully understand and are able to comply with the requirements of the protocol, voluntarily participate and sign the informed consent form. Key Exclusion Criteria: 1. History of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP. 2. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF. 3. Diagnosed with arterial thrombotic disease (such as cerebral thrombosis, transient ischemic attack, myocardial infarction, peripheral arterial disease, etc.); Patients with a history or complications of venous thrombosis (such as deep vein thrombosis, pulmonary embolism); or patients who are using anticoagulants or antiplatelet drugs at the beginning of screening. 4. Subjects who have used romiplostim or its analogs in the past and have not responded. 5. Subjects who have used eltrombopag, haitubopag, avatubopag, recombinant human thrombopoietin (rhTPO), or other drugs with c-MPl stimulating effects within the 4 weeks prior to signing the ICF. 6. Received any anti-malignancy agents (e.g., cyclophosphamide, mercaptopurine, vincristine, vinblastine, interferon-alfa) within 8 weeks prior to signing the ICF. 7. Less than 4 weeks since end of any clinical trials about therapeutic drug or device prior to signing the ICF. 8. Laboratory abnormalities with clinical significance at screening visit. 9. In the opinions of investigators, the patients are not suitable for participation in this trial.

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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

    5 sites. 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

  • Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, 550004, China

  • Hematology Hospital of Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 301609, China

  • Jining First People's Hospital

    RECRUITING

    Jining, Shandong, 272011, China

  • The Second Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650000, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

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