Study of PN20 in Adult Patients With Primary Immune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChongqing Peg-Bio Biopharm Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PN20 treatment
DrugThree dose cohorts, single dose, subcutaneous injections
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: PN20 treatment group-single doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Event (AE)
The incidence of adverse events related to PN20.
Time frame
Treatment and post-treatment follow-up period (28 days after a single dose)Secondary outcomes
1
The percentage of subjects who reach the target therapeutic platelet level after administration
It is defined as the proportion of subjects whose platelet count reaches at least 2 times the baseline platelet count within 28 days after administration and is within the range of 50×10\^9/L to 450×10\^9/L (inclusive).
Time frame
Treatment and post-treatment follow-up period (28 days after a single dose)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov