Study of PN20 in Adult Patients with Primary Immune Thrombocytopenia (ITP)

Launched by CHONGQING PEG-BIO BIOPHARM CO., LTD. · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PN20 for adults with a condition known as primary immune thrombocytopenia (ITP), which is a disorder that leads to low platelet counts and can cause bleeding problems. The main goal of the trial is to find out if PN20 is safe for patients and if it might help increase their platelet levels. Participants in this study will receive one injection of PN20 based on their weight and will need to visit the clinic for follow-up assessments.

To be eligible for this trial, participants must be between 18 and 65 years old, have been diagnosed with ITP for more than six months, and have not had success with previous treatments, including surgery to remove the spleen. Participants should have low platelet counts during the screening process. It’s important to know that individuals with certain medical histories or conditions, such as cancer or specific blood disorders, may not be able to join this study. Overall, this trial offers a chance for patients with ITP to explore a new treatment option while helping researchers learn more about its effects.

Gender

ALL

Eligibility criteria

• 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.