The main aim of this clinical trial is to assess the safety and efficacy of a single dose of PN20 in treatment of thrombocytopenia in adult patients with chronic liver disease undergoing an elective procedure. The main questions it aims to answer are:
* How effective is PN20 in treating thrombocytopenia in patients with chronic liver disease? * Is PN20 safe in these patients? Participants will * Receive a single subcutaneous injections of PN20 or placebo according to weight before an elective procedure, * Visit the clinic for assessment.
Age ≥ 18 years, Male or female
Diagnosed with chronic liver disease-related thrombocytopenia (baseline platelet count < 50 × 10⁹/L), Child-Pugh score A or B;
Planned elective invasive procedure or minor surgery within Days 7-15 post-enrollment, excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection (for tissue biopsy and other types of tissue resection, enrollment is permitted if the investigator considers the risk of bleeding and invasiveness to be comparable to or lower than that of the procedures listed in the surgical examples list);
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Presence of other conditions that may lead to thrombocytopenia;
History of thrombotic or significant cardiovascular events;
Uncontrolled bleeding;
Advanced liver cancer;
Parallel
PN20
Drugsubcutaneous injection
Placebo
Drugsubcutaneous injection
The proportion of responders
Based on the results of hematology tests, calculate the proportion of participants whose platelet counts remained ≥50×10⁹/L from 24 hours pre-surgery through 7 days post-surgery without requiring rescue treatment for bleeding.
Adverse Events
Incidence and severity of all adverse events related to PN20 observed through vital signs, physical examinations, 12-lead ECGs, clinical laboratory tests (including hematology, urinalysis, blood chemistry, coagulation function, and pregnancy tests for women of childbearing potential)
Cmax
Maximum Plasma Concentration
AUC
Area Under the Plasma Concentration-time Curve
Immunogenicity of PN20
Using a validated ELISA assay to detect ADAs against the thrombopoietic peptide and polyethylene glycol
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