Actively Recruiting
Study of PN20 in Adult Patients With Primary Immune Thrombocytopenia (ITP)
Led by Chongqing Peg-Bio Biopharm Co., Ltd. · Updated on 2026-03-02
12
Participants Needed
5
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 safe in these patients? * Could these patients potentially benefit from PN20 treatment? Participants will * Receive one subcutaneous injection of PN20 according to weight; * Visit the clinic for assessment.
CONDITIONS
Official Title
Study of PN20 in Adult Patients With Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years (inclusive), male or female
- Diagnosed with primary immune thrombocytopenia (ITP) for more than 6 months
- No response or relapsed after splenectomy, or not splenectomised but failed at least 1 prior ITP treatment
- Mean of two platelet counts during screening must be less than 30 x 10^9/L, with none above 35 x 10^9/L
- Ability to understand and comply with the protocol and provide informed consent
You will not qualify if you...
- History of bone marrow stem cell disorder or abnormal bone marrow findings other than typical ITP
- Any active malignancy or cancer treatment within 5 years except basal cell carcinoma or cervical carcinoma in situ
- Diagnosed arterial thrombotic disease or history/complications of venous thrombosis; using anticoagulants or antiplatelet drugs at screening
- Previous use of romiplostim or its analogs without response
- Use of eltrombopag, haitubopag, avatubopag, recombinant human thrombopoietin, or similar drugs within 4 weeks before consent
- Received anti-malignancy agents within 8 weeks before consent
- Participation in other therapeutic drug or device trials within 4 weeks before consent
- Laboratory abnormalities of clinical significance at screening
- Considered unsuitable for the trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
2
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
3
Jining First People's Hospital
Jining, Shandong, China, 272011
Actively Recruiting
4
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 301609
Actively Recruiting
5
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650000
Actively Recruiting
Research Team
J
Jing Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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