It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG). This clinical study is conducted to evaluate the efficacy and safety of 5% IVIG in patients with primary Immune Thrombocytopenia (ITP).
The study includes 4 periods and 9 visits (designated as V):
* Screening period (V1: 14 days before the first administration, preliminary examination); * Baseline Period (V2: within 24 h before the first dose, Day 0); * Treatment Period (V3: Day 1 to Day 5, administration of the drug in a hospital setting); * Follow-up Period (V4-V9: visits to Study Site on Day 6, Day 7, Day 14 + 2, Day 21 + 3, Day 28 + 4, and Day 90 (+ 14) after the first dose).
In this study, the investigational product 5% IVIG will be administered at a dose of 0.4 g/kg/day (direct intravenous drip) for 5 consecutive days. The total duration of your participation in the study will be approximately 104 days. The investigational product will only be provided during the study period. It will not be supplied after the study ends.
The study will be conducted at clinical centers in Turkey. It is planned to obtain data from 36 patients included in the study (no more than 48 screened patients).
At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;
Patients with clinically confirmed chronic ITP (i.e., the course of disease > 12 months from diagnosis to signing the informed consent form);
Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2 weeks before the first dose, and did not plan to increase the dosage of glucocorticoids or add other platelet-elevating drugs within 4 weeks after the first dose;
Platelet count < 30 × 109/L;
Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and/or blood products, as well as excipients of the investigational drug, including those with a history of steroid hormone allergy;
BMI ≥ 30 kg/m2;
Secondary thrombocytopenia;
Hemoglobin <90 g/L or combined with immune hemolytic anemia;