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;
Single group
Human immunoglobulin (pH4) for intravenous injection
DrugAdministration: Direct intravenous drip at the initial rate of 1.0 ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, it can be gradually increased. The fastest drip rate should not exceed 3.0 ml/min (about 60 drops/min). Direct intravenous drip, 0.4 g/kg daily for 5 consecutive days. The body weight value is kept as an integer (rounded off), and the dose calculated by body weight is within the allowable range of the theoretical dose ± 5 ml. For example, if the body weight of a patient is 57 kg and the theoretical dosage is 22.8 g/day based on 0.4 g/kg per day of human immunoglobulin for intravenous injection (5%, 5g/100ml strength), 456 ml of drug will be required, so the actual dose ranging from 451 ml to 461 ml is allowable.
Improved platelet response within 7 days of the first transfusion
The response rate is defined as the proportion of patients whose platelet count \> 30 × 109/L and increased to more than 2 times of baseline within 7 days after the first IVIg transfusion and absence of bleeding.
Time to and duration (days) of platelet count > 30 × 109/L
Time to and duration (days) of platelet count \> 30 × 109/L and increased to more than 2-fold baseline within 7 days after the first IVIg infusion without bleeding
Peak and time to peak platelet count
Peak and time to peak platelet count after the first infusion of IVIg (days)
Number and percentage of patients achieving complete response (CR), response (R), non-response (NR) and relapse
Number and percentage of patients achieving complete response (CR), response (R), non-response (NR) and relapse within 28 days after the first infusion
Time to arrival of CR or R response and duration of response
Time to arrival of CR or R response and duration of response within 28 days after the first infusion
Click on the lead sponsor to view all of their trials.
