New shot aims to boost platelets in ITP patients
NCT ID NCT06880081
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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.
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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Affiliated Hospital of Guizhou Medical University
RECRUITINGGuiyang, Guizhou, 550004, China
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Hematology Hospital of Chinese Academy of Medical Sciences
RECRUITINGTianjin, Tianjin Municipality, 301609, China
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Jining First People's Hospital
RECRUITINGJining, Shandong, 272011, China
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The Second Affiliated Hospital of Kunming Medical University
RECRUITINGKunming, Yunnan, 650000, China
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The Second Affiliated Hospital of Nanchang University
RECRUITINGNanchang, Jiangxi, 330006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New hope for kids with ITP: drug combo aims to control bleeding
- New pill could help adults with low platelet disorder
- New drug combo aims to boost platelet counts in immune disorder
- New combo aims to boost platelets in stubborn ITP
- New hope for ITP patients: switching drugs after failed treatment
- New combo therapy aims to tame rare bleeding disorder