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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict accordance with the clinical study protocol.
Exclusion criteria
✕. 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;
What they're measuring
1
Improved platelet response within 7 days of the first transfusion
Timeframe: Within 7 days of the first transfusion
Trial details
NCT IDNCT07233213
SponsorGrand Shuyang Life Sciences (Chengdu) Co., Ltd.
✕. Patients with the following clinical manifestations or disease history at screening:
✕. Patients who failed to respond to previous treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin;
✕. Patients who had received treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin within 4 weeks prior to the first dose, or any other treatment with blood, blood products or blood derivatives within 4 weeks before signing the informed consent form;
✕. Patients who have received recombinant human thrombopoietin or eltrombopag and other receptor agonists within 2 weeks prior to the first dose (except for those who are ineffective after stable treatment \> 2 weeks), or other drugs with clear indications of increasing platelet count;
✕. Patients who have received immunosuppressive or other immunomodulatory drugs within 3 weeks prior to the first dose (except for the following cases: glucocorticoids with stable dose and no dose change for \> 2 weeks, and patients who failed to respond to stable treatment with azathioprine, cyclophosphamide or danazol for \> 12 weeks);