Status:
RECRUITING
Study of PN20 in Adult Patients with Primary Immune Thrombocytopenia (ITP)
Lead Sponsor:
Chongqing Peg-Bio Biopharm Co., Ltd.
Conditions:
Primary Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with primary immune thrombocytopenia (ITP). The main questions it aims to answer are: * Is PN20 ...
Detailed Description
This is a multicenter, open-label, single-arm, dose-escalation Phase1b study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary...
Eligibility Criteria
Inclusion
- Key
- Aged between 18 and 65 years (inclusive), male or female;
- Diagnosed with primary immune thrombocytopenia (ITP) and have a disease course of more than 6 months;
- 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;
- During screening period, the mean of two platelet counts must be \< 30 × 10\^9/L, with none \>35 × 10\^9/L;
- Fully understand and are able to comply with the requirements of the protocol, voluntarily participate and sign the informed consent form.
- Key
Exclusion
- History of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
- 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.
- 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.
- Subjects who have used romiplostim or its analogs in the past and have not responded.
- 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.
- Received any anti-malignancy agents (e.g., cyclophosphamide, mercaptopurine, vincristine, vinblastine, interferon-alfa) within 8 weeks prior to signing the ICF.
- Less than 4 weeks since end of any clinical trials about therapeutic drug or device prior to signing the ICF.
- Laboratory abnormalities with clinical significance at screening visit.
- In the opinions of investigators, the patients are not suitable for participation in this trial.
Key Trial Info
Start Date :
March 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06880081
Start Date
March 7 2025
End Date
October 28 2025
Last Update
March 17 2025
Active Locations (5)
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1
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
2
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
3
Jining First People's Hospital
Jining, Shandong, China, 272011
4
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 301609