A Phase 1/2 interventional study of PN20 and Placebo in Thrombocytopenia Associated With Chronic Liver Disease, sponsored by Chongqing Peg-Bio Biopharm Co., Ltd.. Recruiting at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Chongqing Peg-Bio Biopharm Co., Ltd. · Phase 1/2, Interventional, and Treatment
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:
This is aan open-label, single-dose, dose-escalation phase Ib/II study conducted in two stages, Phase Ib and Phase II, designed to evaluate the safety, tolerability, efficacy, PK, PD, and immunogenicity of PN20 in patients with CLDT in patients with CLDT.
Phase Ib stage is an open-label, single-dose, dose-escalation study. Three dose levels (8 participants per group) will be administered sequentially from low to high.
Phase 2 stage is a randomized, double-blind, single-dose, placebo-controlled study. Eligible patients are randomized in a 1:1 ratio to the treatment or placebo group following informed consent. The dosing regimen in the treatment group is selected based on the Phase Ib results, with one or two dose levels selected. If two PN20 dose levels are selected, randomization follows a 1:1:1 ratio to one of the two treatment groups or to the placebo group.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 54 is close to the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Chongqing Peg-Bio Biopharm Co., Ltd. is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The following conditions or medical history:
Currently using or with a history of the following treatments:
A single subcutaneous injection
Drug: PN20
A single subcutaneous injection
Drug: Placebo
subcutaneous injection
subcutaneous 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.
Time frame: 8 days (from 24 hours pre-surgery through 7 days post-surgery)
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)
Time frame: From dosing of PN20 (Day 1) to Day 28
Cmax
Maximum Plasma Concentration
Time frame: From pre-dose to 8 days after dosing
AUC
Area Under the Plasma Concentration-time Curve
Time frame: From pre-dose to 8 days after dosing
Immunogenicity of PN20
Using a validated ELISA assay to detect ADAs against the thrombopoietic peptide and polyethylene glycol
Time frame: From pre-dose to 28 days after dosing
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Chongqing Peg-Bio Biopharm Co., Ltd.